ACCU-CHEK ® AVIVA TEST STRIPS

MDR report key: 1954674 · Received January 10, 2011

Report

Report Number: 1823260-2011-00148
Event Type: Malfunction
Date Received: January 10, 2011
Date of Event: December 22, 2010
Report Date: April 8, 2011
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ES
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6). CALLER DID NOT PROVIDE PRODUCT INFORMATION FOR THE UNSPECIFIED AVIVA SYSTEM.

Description of Event or Problem · 1

CALLER STATES PATIENT RECEIVED RESULTS OF 578 MG/DL AND 119 MG/DL ON THE AVIVA NANO SYSTEM, AND RESULT OF 119 MG/DL ON AN UNSPECIFIED AVIVA SYSTEM WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

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	202583

Patients

Seq	Age	Sex	Outcome	Treatment
1	003 YR