ACCU-CHEK ® AVIVA TEST STRIPS

MDR report key: 2013191 · Received March 10, 2011

Report

Report Number: 1823260-2011-01309
Event Type: Malfunction
Date Received: March 10, 2011
Date of Event: February 8, 2011
Report Date: April 28, 2011
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

CALLER REPORTED AVIVA BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS 33.3 MMOL/L, "16.?" MMOL/L, 7.7 MMOL/L, AND 7.8 MMOL/L WITHIN 10 MINUTES. THESE RESULTS WERE COMPARED TO A LAB RESULT, THE VALUE OF WHICH THE CUSTOMER DID NOT REMEMBER. NO ADVERSE EVENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK ® AVIVA TEST STRIPS	BLOOD GLUCOSE MONITORING TEST STRIPS	LFR	ROCHE DIAGNOSTICS	NA	302639

Patients

Seq	Age	Sex	Outcome	Treatment
1	048 YR