FDA Adverse Event Injury Summary report: N

ONE TOUCH PING

MDR report key: 1588683 · Received January 22, 2010

Report

Report Number
MW5014482
Event Type
Injury
Date Received
January 22, 2010
Date of Event
October 1, 2009
Report Date
January 22, 2010
Manufacturer
ANIMAS
Product Code
LZG
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I BOUGHT AN ANIMAS -A (B) (4) COMPANY- INSULIN PUMP IN (B) (6) 2008. FROM THE BEGINNING, I HAD PROBLEMS WITH THE PUMP. THE INFUSION SITE WAS CONSTANTLY LEAKING. MY BLOOD SUGAR WOULD BE NORMAL AND THEN WOULD GO UP TO FOUR OR FIVE HUNDRED. I WOULD CHECK THE SITE AND THERE WOULD BE INSULIN LEAKING OUT OF THE SITE WHERE THE TUBING WOULD GO INTO THE CATHETER. I CALLED THE COMPANY AND TOLD THEM ABOUT THIS, SO THEY HAD ME SEND BACK THE WHOLE SET WITH THE TUBING AND ALL. I SENT BACK AT LEAST FIVE SETS AND NO ONE CALLED ME BACK TO LET ME KNOW WHAT THE ISSUE WAS. FINALLY, AFTER ABOUT NINE OR TEN MONTHS, THE CORPORATE OFFICE CALLED AND TOLD ME THERE WAS A BLOCKAGE IN THE TUBING. THEY NEVER OFFERED TO REPLACE ANY OF THE MATERIALS OR SEND ME A NEW PUMP. MY PUMP WAS AND IS STILL UNDER WARRANTY. I ENDED UP STARTING ALL OVER AND BUYING A PUMP WITH (B) (4). THIS PUMP HAS BEEN WONDERFUL AND I HAVE NOT HAD ANY PROBLEMS WITH IT. WHEN I STARTED HAVING PROBLEMS WITH THE ANIMAS PUMP, I WENT TO MY DOCTOR'S OFFICE AND ONE OF THE NURSE EDUCATORS SET ME UP WITH A DIFFERENT INFUSION SET. THAT DIDN'T WORK. ONE OF THE NURSES FROM ANIMAS SET ME UP WITH YET ANOTHER INFUSION SET, AND THAT DIDN'T WORK EITHER. I HAD ALREADY ORDERED A WHOLE BOX OF SUPPLIES FOR THIS PUMP FOR THREE MONTHS. WHEN I DECIDED THAT I HAD ENOUGH, ANIMAS TOLD ME I COULDN'T SEND BACK THESE SUPPLIES EVEN THOUGH THEY WERE IN A SEALED BOX, AND IT HAD NOT BEEN THIRTY DAYS SINCE I RECEIVED THEM WHICH IS THEIR POLICY. THEY HAD TOLD ME THREE TIMES ON A PRIOR OCCASION THAT I COULD SEND THEM BACK AS LONG AS THEY WERE IN A SEALED BOX. THEY NEVER OFFERED TO SEND ME A NEW PUMP OR TO TRY AND FIGURE OUT WHAT THE PROBLEM WAS. I HAVE SPENT A LOT OF MONEY ON THIS AND HAVE HAD VERY HIGH BLOOD SUGARS AS A RESULT. ON ONE OCCASION, I WOKE UP AND MY BLOOD SUGAR WAS THIRTY. MOST PEOPLE DON'T WAKE UP WHEN THEY ARE THAT LOW. THANKFULLY, I DID AND THERE WAS SOMEONE HERE TO HELP ME. THIS WAS AN EXPERIENCE THAT I WOULD NOT WANT ANY OTHER DIABETIC TO HAVE TO DEAL WITH. I HAD TO MISS SOME WORK DUE TO THESE MULTIPLE INCIDENTS, AND THANKFULLY I WORK IN THE MEDICAL FIELD, SO MY COMPANY WAS VERY UNDERSTANDING AND LET ME DO WHATEVER I NEEDED TO DO TO GET MY BLOOD SUGAR UNDER CONTROL. THIS IS NOT HOW AN INSULIN PUMP SHOULD WORK. THE WHOLE POINT IS TO HELP YOUR BLOOD SUGARS STAY UNDER BETTER CONTROL AND THAT IS NOT WHAT HAPPENED IN MY CASE. WHEN I FINALLY GOT TIRED OF MY BLOOD SUGARS STAYING HIGH AND MY PUMP NOT WORKING. I CALLED MY DOCTOR'S OFFICE AND TOOK THE PUMP OFF UNTIL I GOT MY NEW ONE FROM (B) (4). I WENT BACK TO DOING MY OLD WAY OF CONTROLLING MY BLOOD SUGAR WHICH WAS TAKING LANTUS AT BEDTIME AND HUMALOG WHEN I WOULD EAT MEALS. DATES OF USE: (B) (6) 2008 -- (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: TYPE 1 DIABETES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ONE TOUCH PING INSULIN PUMP LZG ANIMAS IPX8 400-274-00

Patients

Seq Age Sex Outcome Treatment
1 26 YR Life Threatening| O