ACCU-CHEK ADVANTAGE

MDR report key: 118722 · Received September 8, 1997

Report

Report Number: 1823260-1997-00074
Event Type: Injury
Date Received: September 8, 1997
Date of Event: July 23, 1997
Report Date: July 24, 1997
Manufacturer: BOEHRINGER MANNHEIM CORP.
Product Code: CFR
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

STANDARD DISCLAIMER ON FILE.

Description of Event or Problem · 1

DIABETIC FELT NAUSEATED, THOUGHT BLOOD SUGAR WAS LOW AT 4AM AND TESTED. SUSPECT DEVICE READ "HI". HE TOOK 20 UNITS OF INSULIN INSTEAD OF 15. HE TESTED "HI" AGAIN, A FEW HOURS LATER. HE TESTED AT NOON AND BLOOD SUGAR WAS "HI". HE TOOK 20 UNITS OF INSULIN AND DID NOT EAT. AT 8PM, WIFE CALLED EMTS AND EMTS GOT A BLOOD GLUCOSE READING OF 20-40 MG/DL. HE WAS GIVEN INTRAVENOUS GLUCOSE. THE HIGH GLUCOSE CONTROL SOLUTION READ OUT OF RANGE. USE OF GLUCOSE CONTROL SOLUTIONS AS A QUALITY CONTROL TEST OF PERFORMANCE IS ADDRESSED IN THE LABELING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK ADVANTAGE	BLOOD GLUCOSE MONITORING SYSTEM	CFR	BOEHRINGER MANNHEIM CORP.	768(METER)	400437(STRIPS)

Patients

Seq	Age	Sex	Outcome	Treatment
1	71 YR		Life Threatening