FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK AVIVA COMBO

MDR report key: 2850141 · Received November 21, 2012

Report

Report Number: 2183996-2012-01778
Event Type: Malfunction
Date Received: November 21, 2012
Date of Event: September 26, 2012
Report Date: November 18, 2012
Manufacturer: ROCHE INSULIN DELIVERY SYSTEMS INC
Product Code: NBW
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

PT REPORTED E-57 (ELECTRONIC) ERROR WAS DISPLAYED ON THE BLOOD GLUCOSE METER. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE BLOOD GLUCOSE METER WAS REQUESTED TO BE RETURNED FOR EVAL. PRELIMINARY EVAL FOUND THAT MG/DL IS ON THE METER BACK LABEL, HOWEVER, CONTROL RESULTS WERE DISPLAYED IN MMOL/L. PREVIOUS RESULTS IN METER MEMORY ARE LISTED IN MMOL/L. METER WAS SENT FOR ROOT CAUSE FAILURE ANALYSIS. ROOT CAUSE FAILURE ANALYSIS INDICATES THAT THIS FAILURE IS DUE TO A SERIAL FLASH MEMORY CORRUPTION, WHICH YIELDED AN E57 ERROR TO DISPLAY ON THE METER WHEN TESTING WITH BLOOD. DUE TO THIS FAILURE, THE FLASH MEMORY IS CLEARED WHICH ALSO RESULTS IN THE METER MEMORY DISPLAYING UNITS IN MMOL/L RATHER THAN MG/DL. THE METER IS STILL CAPABLE OF PROVIDING VALUES WITH CONTROLS ONLY, BUT THEY WILL BE IN THE INCORRECT UNITS OF MEASURE (MMOL/L ONLY).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK AVIVA COMBO		NBW	ROCHE INSULIN DELIVERY SYSTEMS INC	00700006577	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				RELATED ACCESSORIES\| INSULIN INFUSION PUMP\| INSULIN