FDA Adverse Event Injury Summary report: N

OMNIPOD PDM

MDR report key: 3679703 · Received March 11, 2014

Report

Report Number
MW5034934
Event Type
Injury
Date Received
March 11, 2014
Date of Event
February 19, 2014
Report Date
March 10, 2014
Manufacturer
INSULET CORP
Product Code
LZG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I RECEIVED A PRODUCT RECALL LETTER FROM INSULET CORPORATION DATED 02/19/2014 STATING THAT THE FREESTYLE TEST STRIPS FROM ABBOTT DIABETES CARE WERE DEFECTIVE AND PRODUCED ERRONEOUS LOW READINGS WHEN USED WITH MY OMNIPOD PERSONAL DIABETES MANAGER. THE LETTER HAD A SEPARATE LETTER FROM ABBOTT ENCLOSED WITH A PHONE NUMBER (B)(6) AND DIRECTIONS TO CALL IMMEDIATELY AND REQUEST REPLACEMENT STRIPS. I CALLED AND GAVE THE REP WHO ANSWERED THE PHONE MY INFO AND THEY STATED THAT THEY WOULD SHIP THE REPLACEMENT STRIPS AND I WOULD HAVE THEM THE NEXT DAY. NOTHING EVER ARRIVED SO I CALLED INSULET CORP (B)(4) ON (B)(6) 2014 TO ESCALATE THE ISSUE TO THE NEXT LEVEL. THEY PLACED ME ON HOLD WHILE THEY CALLED ABBOTT, AND THE INSULET REP TOLD ME THAT ABBOTT DID HAVE MY ORDER BUT HAD NOT SHIPPED IT AND ADMITTED IT WAS THEIR ERROR. THEY THEN SAID ABBOTT PROMISED AGAIN THAT THEY WOULD SHIP THE REPLACEMENT TEST STRIPS IMMEDIATELY AND I WOULD HAVE THEM THE NEXT DAY. YET AGAIN, NO REPLACEMENT TEST STRIPS EVER ARRIVED. SO NOW, I AM ESCALATING THIS TO THE NEXT LEVEL YOU, CONGRATULATIONS, YOU NOW GET THE PLEASURE OF CONTACTING THEM AND SEEING IF YOU HAVE ANY SUCCESS MAKING THESE PEOPLE DO THEIR JOBS. GOOD LUCK DEALING WITH THESE FOLKS, AND LET ME KNOW HOW IT COMES OUT. I CAN BE CONTACTED AT (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
146248 OMNIPOD PDM OMNIPOD PDM LZG INSULET CORP NA

Patients

Seq Age Sex Outcome Treatment
1 59 YR Required Intervention