FDA Adverse Event Injury Summary report: N

SILHOUTTE PARADIGM INFUSION SET

MDR report key: 6875923 · Received September 18, 2017

Report

Report Number
MW5072202
Event Type
Injury
Date Received
September 18, 2017
Date of Event
August 16, 2017
Report Date
September 17, 2017
Manufacturer
MEDTRONIC
Product Code
LZG
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2017 AROUND 2:30 AM, I FELL INTO A DIABETIC COMA AND REQUIRED THE EMERGENCY SERVICES OF THE (B)(6) PARAMEDICS WHEN MY PARTNER HEARD ME BREATHING STRANGELY AND WAS NOT ABLE TO AROUSE ME. THE PARAMEDICS CHECKED MY BLOOD SUGAR AND IT WAS SO LOW THEY WERE NOT ABLE TO GET A READING. THEY WERE ABLE TO TREAT ME AND EVENTUALLY REVIVE ME AFTER ABOUT 1/2 HOUR. IT WAS VERY CONFUSING THAT THIS HAPPENED BECAUSE I HAD GONE TO BED WITH MY BLOOD SUGAR AT A HIGH ENOUGH LEVEL TO GET ME THROUGH THE NIGHT AND THERE WAS NO INDICATION FROM MY INSULIN PUMP THAT I HAD RECEIVED ANY EXTRA DOSAGE OF INSULIN OVERNIGHT. UNFORTUNATELY MY CONTINUOUS GLUCOSE MONITOR HAD NOT BEEN WORKING CONSISTENTLY AND I WAS UNABLE TO GET A REPLACEMENT. I RECENTLY FOUND OUT ABOUT A RECALL OF MEDTRONIC'S MMT-381 INFUSION SETS, LOT 5150522, WHICH ARE WHAT I HAVE BEEN USING AND THE LOT NUMBER MATCHED THOSE I WAS AT THE TIME OF MY EVENT. IT LEADS ME TO BELIEVE THAT MY HYPOGLYCEMIC COMA WAS DUE TO THE FAILURE OF THEIR PRODUCT SINCE THERE WAS NO OTHER EXPLANATION AS TO WHY MY BLOOD SUGAR WOULD HAVE DROPPED SO LOW. THAT EPISODE WAS VERY UNSETTLING AND CAUSED ME A GREAT DEAL OF EMOTIONAL DISTRESS AND MORE. I HOPE NO ONE DIED AS A RESULT, WHICH COULD HAVE HAPPENED TO ME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
652228 SILHOUTTE PARADIGM INFUSION SET PUMP, INFUSION, INSULIN LZG MEDTRONIC MMT-381 5150522

Patients

Seq Age Sex Outcome Treatment
1 54 YR Life Threatening