FDA Adverse Event Death Summary report: N

FREESTYLE TEST STRIPS GDH-PQQ, FREESTYLE METER

MDR report key: 1741354 · Received June 24, 2010

Report

Report Number
MW5016514
Event Type
Death
Date Received
June 24, 2010
Date of Event
July 16, 2007
Report Date
June 16, 2010
Manufacturer
ABBOTT DIABETICS CARE INC.
Product Code
LZG
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE PROBLEMS STARTED IN 2004 WITH OCCASIONAL HYPOGLYCEMIC EPISODES WHICH INCLUDED LOSS OF CONSCIOUSNESS. THE EPISODES BECAME MORE FREQUENT WITH VERY UNUSUAL BEHAVIOR. TALKED TO DOCTORS REGARDING HIS LOW BLOOD SUGARS BECAUSE (B) (6) COULD NOT UNDERSTAND WHY IT WOULD DROP SO LOW! THE DOCTORS DID NOTHING BUT, TOLD US TO DISCONNECT HIS PUMP AND USE A GLUCAGON INJECTION. I TOOK (B) (6) TO THE BOSTON CLINIC IN (B) (6) 2007 AND SENT MANY GLUCOSE METERS TO BE CHECKED OUT BY ABBOTT LAB DUE TO THE INACCURATE READINGS OF HIGHS AND LOWS. THEY FOUND NOTHING WRONG WITH THE METERS BUT GAVE NO ANSWERS TO THE UNCONTROLLABLE BLOOD SUGARS. WE USED 12 GLUCAGON INJECTIONS IN 8 MONTHS AND CALLED 911 FOR MEDSTAR AMBULANCE FOR HELP!! (B) (6) SUFFERED TERRIBLY AND WAS NOT THE SAME PERSON ANYMORE! HE HAD SEIZURES, LOSS OF MEMORY AND ANXIETY ATTACKS. HE WAS MOST OF ALL VERY UPSET THAT HE COULD NOT FIGURE OUT WHAT WAS GOING ON WITH HIS HEALTH, AND HE TOOK VERY GOOD CARE OF HIMSELF. HE WAS ON THE MEDTRONIC MINIMED PARADIGM PUMP AND WAS VERY GOOD ABOUT WATCHING HIS CARBOHYDRATE INTAKE. WE WOULD FIND HIM PASSED OUT WITH NO WARNING AND COMPLETELY UNRESPONSIVE! FRANK WAS VERY SAVVY PUMP USER, AND THE PUMP TRAINER IN BOSTON WAS IMPRESSED WITH HIS PUMP SKILLS. WE HAD MANY EMERGENCY SITUATIONS WITH BLOOD SUGARS AS LOW AS 28 AND (B) (6) WOULD ARGUE WITH US AND HAD NO RECOLLECTION OF WHAT HAPPENED. HE WOULD BEHAVE AS IF HE WAS DRUNK AND EACH EPISODE BECAME WORSE WHICH WAS DESTROYING HIM EACH TIME AND TOOK SO MUCH OUT OF HIM!!! I WAS WITH (B) (6) AT 3:00 IN THE MORNING AND MADE HIM A SANDWICH BECAUSE HE FELT LIKE HIS BLOOD SUGAR WAS LOW. AT 4:00, I CHECKED ON HIM, AND HE SAID HE WAS FINE AND FOR ME TO GO TO BED. IN THE MORNING I WENT TO CHECK ON HIM AND FOUND HIM FACE DOWN IN HIS ROOM AT 9:34 AM BETWEEN HIS DRESSER AND BED. I RAN TO GET A GLUCAGON INJECTION WHICH I GAVE HIM. MY DAUGHTER CAME OVER, SHE LIVES ON THE NEXT BLOCK AND FLIPPED (B) (6) OVER, HIS FACE WAS BLUE WHEN WE TURNED (B) (6) OVER. SHE CALLED 911 AND TRIED TO DO CPR!! THE EMS CAME AND TOOK (B) (6) TO THE HOSPITAL, WHERE OUR WORST NIGHTMARE CAME TRUE. MY WONDERFUL, HANDSOME, KIND, LOVING SON (B) (6) WAS GONE ON (B) (6) 2007. (B) (6) WAS A JUVENILE DIABETIC FROM THE AGE OF (B) (6) AND NEVER SUFFERED LIKE HE DID IN THE LAST YEAR OF HIS LIFE!! HE HAD NO HEART, KIDNEY OR MAJOR COMPLICATIONS FROM HIS DIABETES!! MEDTRONIC PARADIGM INSULIN PUMP (B) (4), CONF B8S4, (B) (4), MEDTRONIC MINI MED QUICK SET MMT-396 LOT 2202145, SMITH AND NEPHEW IV PREP ANTISEPTIC WIPE, MATISOL LIQUID ADHESIVE, DETACHOL ADHESIVE REMOVER, THE FREESTYLE GLUCOSE METERS (B) (6) USED ARE LOT G102A5, (B) (4), LOT 02KD44D, (B) (4), LOT 01K61D, (B) (4), (B) (4), (B) (4), FREESTYLE LOT C307A, (B) (4), MEDTRONIC MINI MED B&D (B) (4) THESE ARE SOME METERS THAT WE HAVE THE EMPTY BOXES. THE GLUCOSE METER WE HAVE WAS SENT TO (B) (6) IN (B) (6) 2007 DUE TO PROBLEMS WITH THE OTHER. THE METER WE SENT HAD MOST OF (B) (6) GLUCOSE READINGS. WHEN I CALLED THEM TO TELL THEM (B) (6) DIED, THEY INSISTED I SEND THEM THE METER AND TEST STRIPS! THEY EVEN SENT PACKAGING TO RETURN EVERYTHING, I DID NOT SEND IT TO THEM!!! I HAVE ALL THE TEST STRIPS AND THE METER HE WAS USING WHEN HE DIED WHICH WAS THE (B) (4) FREESTYLE FLASH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FREESTYLE TEST STRIPS GDH-PQQ, FREESTYLE METER GLUCOSE TEST STRIPS LZG ABBOTT DIABETICS CARE INC. 0702225
10 MEDTRONIC MINI MED B&D NONE NBW ABBOTT DIABETICS CARE INC. 023470-3198B
11 FREESTYLE FLASH NONE NBW ABBOTT DIABETICS CARE INC.
2 MEDTRONIC PARADIGM INSULIN PUMP NONE LZG ABBOTT DIABETICS CARE INC. MMT-515 L NAS, CONF B8S4
3 MEDTRONIC MINI MED QUICK SET NONE FPA ABBOTT DIABETICS CARE INC. 2202145
4 MATISOL LIQUID ADHESIVE NONE KMF ABBOTT DIABETICS CARE INC.
5 DETACHOL ADHESIVE REMOVER NONE KOX ABBOTT DIABETICS CARE INC.
6 FREESTYLE GLUCOSE METERS NONE NBW ABBOTT DIABETICS CARE INC. G102A5, DAGK0 7-61103
7 FREESTYLE GLUCOSE METERS NONE NBW ABBOTT DIABETICS CARE INC. 02KD44D,DAGK031-616687
8 FREESTYLE GLUCOSE METERS NONE NBW ABBOTT DIABETICS CARE INC. 01K61D,T-G072-63865,R-F028-620
9 FREESTYLE NONE NBW ABBOTT DIABETICS CARE INC. C307A,K-E078-61359

Patients

Seq Age Sex Outcome Treatment
1 34 YR Death| L| O SMITH AND NEPHEW IV PREP ANTISEPTIC WIPE