FDA Adverse Event Malfunction Summary report: N

OMNIPOD

MDR report key: 3688187 · Received March 13, 2014

Report

Report Number
MW5034971
Event Type
Malfunction
Date Received
March 13, 2014
Date of Event
March 12, 2014
Report Date
March 12, 2014
Manufacturer
INSULET CORPORATION
Product Code
LZG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

INSULET CORPORATION'S OMNIPOD PERSONAL DIABETES MANAGEMENT SYSTEM ROUTINE MALFUNCTIONS. ROUTINE POD FAILURES (ALARM CODE 19-000-0000-00064) WITH A FAILURE RATE OF APPROX (B)(6). CUSTOMER SERVICE ALWAYS REPLACES FAILED PODS "AS A COURTESY" BUT AS ANOTHER REPORT MENTIONED, THEY NEVER COMPENSATE YOU FOR YOUR WASTED INSULIN IN THE FAILED POD. IN MY CASE THIS EQUATES TO SEVERAL HUNDRED DOLLARS PER YEAR. I SHOULD NOTE I AM STILL USING THE OLD OMNIPOD SYSTEM, NOT THE "NEW OMNIPOD SYSTEM." I DID PURCHASE THE "NEW OMNIPOD SYSTEM" IN EARLY (B)(6) DUE TO INSURANCE INCENTIVES EVEN THOUGH I HAD A 3 MONTHS SUPPLY OF OLD PODS STILL ON HAND. SINCE THAT PURCHASE, I CONTINUE TO USE THE OLD SYSTEM TO UTILIZE MY OLD POD SUPPLY BUT INSULET HAS CONTINUED TO REPLACE MY FAILED PODS WITH THE OLD PODS IN SPITE OF MY FREQUENT REQUEST TO PLEASE REPLACE WITH THE "NEW OMNIPOD SYSTEM" PODS. INSULET HAS SENT OVER 10 OLD POD REPLACEMENTS IN THE LAST 3 MONTHS AND TO MY AMAZEMENT, OMNIPOD CUSTOMER SERVICE RECENTLY TOLD ME "THEY DID NOT KNOW I HAD THE "NEW OMNIPOD SYSTEM." HOW CAN THE MANUFACTURE OF A MULTI THOUSAND DOLLAR MEDICAL PRODUCT NOT KNOW WHO PURCHASES THEIR PRODUCTS...ESPECIALLY AFTER BEING TOLD AT LEAST SIX DIFFERENT TIMES BY THE CONSUMER? I AM GENERALLY HAPPY WITH THE OMNIPOD SYSTEM BUT HOPE THE "NEW OMNIPOD SYSTEM" WILL PROVE MORE RELIABLE. INSULET CORPORATION MOST DEFINITELY NEEDS TO ADDRESS QUALITY AND CONSUMER INFO RETENTION/CONSUMER RESPONSE. I EMAILED A SIMILAR EMAIL WEEKS AGO TO INSULET CORPORATION WITH NO RESPONSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
151619 OMNIPOD OMNIPOD LZG INSULET CORPORATION OLD OMNIPOD SYSTEM

Patients

Seq Age Sex Outcome Treatment
1 54 YR