FDA Adverse Event Injury Summary report: N

MEDTRONIC MINIMED

MDR report key: 1431518 · Received July 26, 2009

Report

Report Number
MW5012209
Event Type
Injury
Date Received
July 26, 2009
Date of Event
July 26, 2009
Report Date
July 26, 2009
Manufacturer
MEDTRONIC, INC.
Product Code
FPA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAVE TYPE I DIABETES AND RECENTLY- EXPERIENCED REPEATED OCCASIONS OF MY BG BECOMING INCREDIBLY HIGH - 400+/- -. BELIEVING MY INSULIN WAS DETERIORATING, AND NEVER SUSPECTING MY INSULIN PUMP OR RELATED EQUIPMENT, I THREW SOME AWAY AND RETURNED SOME TO THE PHARMACY. MORE RECENTLY, I RECEIVED THE MINIMED INFUSION SET RECALL NOTICE - WHICH EXPLAINED MY EXPERIENCE OF EARLY JUNE - ALTHOUGH STILL WAS SOMEWHAT PUZZLING, HOW I EXPERIENCED 3 DEFECTIVE SETS IN A ROW - REPLACING EVERY COUPLE DAYS, AS MY BG SKYROCKETED APPROX 24-36 HOURS AFTER I REPLACED EACH SET. I RETURNED ALL OF MY LOT 8 QUICK-SET INFUSION SETS - PER INSTRUCTIONS - AND AM NOW USING SETS FROM LOT 9200010. LAST NIGHT, ARRIVING HOME AROUND MIDNIGHT, MY ROUTINE BG TEST WAS OVER 480! - THIS WAS A RECENTLY FILLED INFUSION SET - EARLIER IN THE DAY. ASSUMING THAT I MUST HAVE BEEN DISTRACTED OR INATTENTIVE OVER DINNER WITH FRIENDS - OR THAT I HAD CONSUMED "HIDDEN" SUGAR, I GAVE A LARGE BOLUS OF INSULIN, SET MY ALARM FOR 1 HOUR AND, BECAUSE EXHAUSTED, WENT TO BED. AN HOUR LATER, INSTEAD OF A DECREASING BG, I LEARNED I WAS OVER 550! THEREFORE, I REFILLED MY PUMP, DELIVERED ANOTHER LARGE INSULIN BOLUS AND AGAIN SET MY ALARM FOR 1 HOUR LATER. MY NEXT TEST REVEALED THAT WHILE I WAS STILL OVER 400, MY BG WAS INDEED MOVING DOWNWARD. THIS MORNING, IT WAS 193 - I DEFERRED BREAKFAST, ADMINISTERED ANOTHER BOLUS AND TIRED FROM THE SLEEP PATTERNS, WENT BACK TO BED. ANOTHER HOUR LATER, MY BG WAS 130, SO I ATE A MODEST BREAKFAST AND DELIVERED INSULIN. THAT WAS ABOUT 30 MINUTES AGO. I AM HOPEFUL THAT THIS SET IS DELIVERING AS IT SHOULD, BUT AM ALSO CONCERNED THAT THE ONLY SIMILAR EXPERIENCES I HAVE HAD WAS DURING THAT WEEK. IT IS FRIGHTENING TO LIVE WITH SO MUCH OF MY TIME AND ENERGY DEVOTED TO MANAGING MY BG AND ASSOCIATED FATIGUE AND HEADACHES. I HAVE WORN MINIMED INSULIN PUMPS SINCE APPROXIMATELY 1988, AND USUALLY SUCCESSFULLY MANAGE BG IN THE BACKGROUND WHILE PRACTICING LAW, CYCLING, HIKING, WALKING COOKING, WEEDING THE HERBS, ETC. IF YOU ARE RECEIVING CONCERNS FROM OTHERS USING OTHER-THAN-LOT 8 SETS, I TRULY HOPE THAT THIS INFO ALLOWS FOR EARLIER IDENTIFICATION AND NOTIFICATION, SO THAT PTS CAN AGAIN LEARN TO RELY ON THESE DEVICES. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC MINIMED QUICK-SET INFUSION SET FPA MEDTRONIC, INC. 9200010

Patients

Seq Age Sex Outcome Treatment
1 54 YR