FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK ® AVIVA TEST STRIPS

MDR report key: 1860037 · Received October 7, 2010

Report

Report Number: 1823260-2010-06012
Event Type: Malfunction
Date Received: October 7, 2010
Date of Event: October 4, 2010
Report Date: October 27, 2010
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: K043474
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH REPORT IS FOR THE CUSTOMER'S AVIVA SYSTEM. (B)(4).

Description of Event or Problem · 1

CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 39 MG/DL AND 160 MG/DL; 160 MG/DL AND 47 MG/DL. SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 160 MG/DL (CUSTOMER'S AVIVA) AND 66 MG/DL (FATHER'S AVIVA) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

Description of Event or Problem · 1

THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO REPORT AN I-PUMP IN WHICH, WHILE A NURSE CHANGED THE EPIDURAL BAG, IT WAS NOTICED THAT THE ALARM DID NOT SOUND ON OPENING THE DOOR OF THE DEVICE. THE DEVICE WOULD NOT ALLOW THE NURSE TO CHANGE THE VOLUME WHEN THE NEW BAG WAS ERECTED. THERE WAS NO ADVERSE EVENT, PATIENT INJURY, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

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		302489

Patients

Seq	Age	Sex	Outcome	Treatment
1				CONTINOUS GLUCOSE MONITOR - TYPE UNKNOWN\| LANTUS\| HUMALOG