ACCU-CHEK ® AVIVA TEST STRIPS

MDR report key: 2613231 · Received June 12, 2012

Report

Report Number: 1823260-2012-03102
Event Type: Malfunction
Date Received: June 12, 2012
Date of Event: May 29, 2012
Report Date: July 2, 2012
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GB
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 SYSTEM BLOOD GLUCOSE RESULTS OF 2.7 MMOL/L, 3.3 MMOL/L, HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 33.3 MMOL/L, AND 4.1 MMOL/L WITHIN 10 MINUTES. DURING THIS TIME, THE CUSTOMER DRANK APPROXIMATELY 100 ML OF LUCOZADE. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

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	00700006575	490610

Patients

Seq	Age	Sex	Outcome	Treatment
1	013 YR