ACCU-CHEK ® AVIVA TEST STRIPS

MDR report key: 3647534 · Received February 26, 2014

Report

Report Number: 1823260-2014-01321
Event Type: Malfunction
Date Received: February 26, 2014
Date of Event: January 25, 2014
Report Date: July 28, 2025
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
Health Professional: N

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE AVIVA NANO SYSTEM WITHIN 2 MINUTES: 30.6 MMOL/L, HI (RESULT > 33.3 MMOL/L) AND 12.5 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
119143	ACCU-CHEK ® AVIVA TEST STRIPS	BLOOD GLUCOSE MONITORING TEST STRIPS	LFR	ROCHE DIAGNOSTICS	NA	491993

Patients

Seq	Age	Sex	Outcome	Treatment
1	87 YR	Female