-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, A/EP04kfYPcSJsAmgzD6SZ7JWSxrmCKOI1BdvxC9jB76KYCXbmySCCI0PO6dZEYO JLBZLW+1YZgwaNcTPhfRmg== 0000950148-99-002541.txt : 19991122 0000950148-99-002541.hdr.sgml : 19991122 ACCESSION NUMBER: 0000950148-99-002541 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19991119 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 19991119 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MINIMED INC CENTRAL INDEX KEY: 0000945801 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 954408171 STATE OF INCORPORATION: DE FISCAL YEAR END: 0101 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-26268 FILM NUMBER: 99760731 BUSINESS ADDRESS: STREET 1: 12744 SAN FERNANDO RD CITY: SYLMAR STATE: CA ZIP: 91342 BUSINESS PHONE: 8183625958 MAIL ADDRESS: STREET 1: 12744 SAN FERNANDO RD CITY: SYLMAR STATE: CA ZIP: 91342 8-K 1 FORM 8-K 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported) November 19, 1999 ----------------------------- MINIMED INC. - ------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in its Charter) Delaware 0-26268 95-4408171 - ---------------------------- ------------- ------------------- (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 12744 San Fernando Road, Sylmar, California 91342 - -------------------------------------------- ---------- (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code (818) 362-5958 ------------------------- N/A - ------------------------------------------------------------------------------- (Former Name or Former Address, if Changed Since Last Report) 2 ITEM 5. OTHER EVENTS. On November 19, 1999, MiniMed Inc. announced a patient notification relating to its Model 508 insulin infusion pump. The press release filed as an exhibit hereto, and incorporated by reference herein, provides additional details regarding the patient notification. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS. The Exhibits to this report are listed in the Index to Exhibits on page 3. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: November 19, 1999 MINIMED INC. By: /s/ Eric S Kentor -------------------------------- Name: Eric S. Kentor Its: Senior Vice President, General Counsel and Secretary 2 3 INDEX TO EXHIBITS Exhibit No. Description - ----------- ----------- 99.1 Press release dated November 19, 1999 3 EX-99.1 2 EXHIBIT 99.1 1 NEWS RELEASE For: MiniMed Inc. Contact: Terrance H. Gregg President and Chief Operating Officer Kevin R. Sayer Senior Vice President and Chief Financial Officer 818-362-5958 FOR IMMEDIATE RELEASE Investor Relations Robert P. Jones/Ephraim R. Bernstein (212) 850-5600 Media: Sheryl Seapy 415-296-7383 Morgen-Walke Associates MINIMED INC. ANNOUNCES PATIENT NOTIFICATION Sylmar, California, November 19, 1999 -- MiniMed Inc. (Nasdaq: MNMD) announced today that it is initiating a patient notification procedure relating to a rare and minor software error which could occur in certain of its Model 508 insulin infusion pumps distributed since October 1999. MiniMed reported that this situation may be created by a very specific programming sequence that some users may possibly follow. The company stated that the issue has been addressed, and all products shipped beginning today contain an upgraded version of the software. Alfred E. Mann, MiniMed's Chairman and CEO, stated, "This situation was identified quickly as a result of the strict performance monitoring which we conduct on all of our products. A notification containing programming instructions which will eliminate this potential occurrence has been sent to those pump users who purchased Model 508 pumps from October 4 through November 18. We believe that the MiniMed 508 offers the state of the art in safety, reliability and clinical benefit for patients who treat their diabetes with continuous insulin infusion." Terrance H. Gregg, MiniMed's President and Chief Operating Officer, added, "Our independent medical monitor confirmed for us that this anomaly does not represent an urgent matter. In addition to the patient notification, we will upgrade the software in the affected pumps early next year. Our estimated cost for this activity is expected to range between $1 million and $1.5 million." 2 MiniMed Inc. designs, develops, manufactures and markets advanced infusion systems with a primary emphasis on the intensive management of diabetes. The Company's products include external pumps and related disposables, a continuous glucose monitoring system product and the distribution of an implantable insulin pump, which is currently approved for sale in the European Community and has not yet been cleared for marketing in the U.S. The Company also distributes other diabetes supplies and pharmaceutical products. ___________________ Any statements made by MiniMed in this press release that are forward-looking, including statements relating to the costs associated with upgrading the software in affected pumps, are made pursuant to the Safe Harbor provisions of the Private Securities Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect MiniMed's business and prospects, including changes in economic and market conditions, the number of MiniMed employees or outside consultants available to upgrade the affected pumps, administration and regulatory approval and related considerations and other factors discussed in the Company's filings with the Securities and Exchange Commission. ### -----END PRIVACY-ENHANCED MESSAGE-----