ACCU-CHEK ® COMPACT TEST DRUM

MDR report key: 2823003 · Received November 7, 2012

Report

Report Number: 1823260-2012-05654
Event Type: Malfunction
Date Received: November 7, 2012
Date of Event: October 12, 2012
Report Date: November 7, 2012
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

CUSTOMER REPORTEDLY, RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 24 MG/DL, 25 MG/DL, 29 MG/DL, AND 150 MG/DL. 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 ® COMPACT TEST DRUM	BLOOD GLUCOSE MONITORING TEST STRIPS	LFR	ROCHE DIAGNOSTICS	NA	208055

Patients

Seq	Age	Sex	Outcome	Treatment
1	079 YR