FDA Adverse Event Injury Summary report: N

ACCU-CHEK ® AVIVA

MDR report key: 1812992 · Received August 24, 2010

Report

Report Number: 1823260-2010-05032
Event Type: Injury
Date Received: August 24, 2010
Date of Event: July 26, 2010
Report Date: August 27, 2010
Manufacturer: ROCHE DIAGNOSTICS
Product Code: NBW
PMA / PMN Number: K043474
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

CUSTOMER REPORTED THAT SHE WAS RECENTLY DIAGNOSED WITH GASTRITIS AND HAD LOWER ACTIVITY AND EATING LEVELS. SHE WAS NOT TAKING ANY MEDICATIONS OTHER THAN HER INSULIN PUMP (LEVELS NOT PROVIDED). SHE WAS FOUND UNCONSCIOUS BY HER BOYFRIEND. HE ATTEMPTED TO OBTAIN A BLOOD GLUCOSE READING WITH AN AVIVA METER, BUT WAS UNABLE TO (REASON NOT PROVIDED). HE CALLED FOR AN AMBULANCE; THE PARAMEDICS ATTEMPTED TO RAISE HER BLOOD GLUCOSE LEVELS BUT WERE UNSUCCESSFUL. SHE WAS TRANSPORTED TO THE HOSPITAL. AT THE HOSPITAL, SHE WAS TREATED WITH IVS (CONTENTS UNKNOWN) AND PAIN MEDICATION. A BLOOD GLUCOSE READING WAS OBTAINED IN THE HOSPITAL (RESULT UNKNOWN). REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

Description of Event or Problem · 1

IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT THE PT IS HAVING AN INCREASE OF SEIZURE ACTIVITY AND THE MAGNET IS NOT HELPING IN ABORTING SEIZURE. PHYSICIAN FELT THAT THE BATTERY IS LIKELY NEAR END OF SERVICE AND WORKING INTERMITTENTLY. DIAGNOSTICS RESULTS SHOWED EVERYTHING WORKING WITHIN NORMAL LIMITS. PT HAD HIS BATTERY REPLACED. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAS BEEN UNSUCCESSFUL TO DATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK ® AVIVA	BLOOD GLUCOSE MONITORING DEVICE	NBW	ROCHE DIAGNOSTICS	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	037 YR		Hospitalization	INSULIN - TYPE UNKNOWN\| INSULIN PUMP - TYPE UNKNOWN