UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): April 11, 2016
DexCom, Inc.
(Exact Name of the Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
| 000-51222 | 33-0857544 | |
| (Commission File Number) | (IRS Employer Identification No.) | |
| 6340 Sequence Drive, San Diego, CA | 92121 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
(858) 200-0200
(Registrant’s Telephone Number, Including Area Code)
(Former Name or Former Address, If Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| ITEM 8.01. | OTHER EVENTS. |
On April 11, 2016, DexCom issued a press release announcing supplements to its previous customer notification, which disclosure also supplements DexCom’s earlier disclosures on this matter contained in its Annual Report on Form 10-K filed on February 23, 2016. The press release is being filed as Exhibit 99.01 to this report and is incorporated herein by this reference.
| ITEM 9.01. | FINANCIAL STATEMENTS AND EXHIBITS. |
(d) Exhibits.
| Number |
Description | |
| 99.1 | Press release dated April 11, 2016 | |
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 thereunto duly authorized.
| DEXCOM, INC. | ||
| By: | /s/ Steven R. Pacelli | |
| Steven R. Pacelli | ||
| Executive Vice President, Strategy and Corporate Development | ||
Date: April 11, 2016
Exhibit 99.1
Dexcom, Inc. Issues Press Release To Supplement Previous Customer Notification
SAN DIEGO, April 11, 2016 /PRNewswire/ — Dexcom, Inc. (NASDAQ: DXCM) issues this press release to supplement its previous customer notification and remind its patients to periodically test the audible alarms and alerts on certain receivers manufactured by Dexcom to make sure that the audible alarms and alerts are functioning properly. The notification constituted a voluntary recall and applied to those Dexcom G4 Platinum Receivers, Dexcom G4 Platinum Pediatric Receivers, Dexcom G4 Platinum Professional Receivers, Dexcom G4 Platinum with Share Receivers, Dexcom G4 Platinum with Share Pediatric Receivers and the Dexcom G5 Mobile Receivers that are experiencing problems with audible alarms and alerts. There is no reason for patients to return receivers to Dexcom that are functioning properly.
Dexcom issued the customer notification on February 23, 2016 via its website and certified mail to patients. The notification alerted customers of a potential issue affecting the audible alarms and alerts associated with the speaker component of certain receivers. Dexcom notified customers about this potential issue after receiving customer complaints about the receivers’ speaker component. Specifically, the speaker failed to properly provide audible alerts and alarms in some or all instances.
Customers who rely on audible alerts and alarms may not be notified of severe hypoglycemia or hyperglycemia if the speaker in their receiver does not function properly. The immediate health consequences of severe hypoglycemia include loss of consciousness, seizure, and in rare instances death.
Patients with questions regarding the notification, or who would like to notify Dexcom that the audible alarms and alerts on their receiver are not functioning properly, should call our dedicated hotline toll free at (844) 607-8398 or visit our website at www.dexcom.com/notification.
Adverse reactions experienced with the use of any Dexcom products should also be reported to FDA’s MedWatch Adverse Event Reporting program by:
| • | completing and submitting the report online at www.fda.gov/medwatch/report.htm; or |
| • | downloading and completing the form, then submitting it via fax to 800-FDA-0178. |
About Dexcom, Inc.
DexCom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for ambulatory use by people with diabetes and by healthcare providers in the hospital. For additional information, visit the company’s website at www.dexcom.com.
INVESTOR CONTACT:
Steven R. Pacelli
Executive Vice President, Strategy and Corporate Development
858-200-0200