ACCU-CHEK ® PERFORMA TEST STRIPS

MDR report key: 1955379 · Received January 10, 2011

Report

Report Number: 1823260-2011-00165
Event Type: Malfunction
Date Received: January 10, 2011
Date of Event: December 27, 2010
Report Date: March 10, 2011
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: NA
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UY
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 PERFORMA SYSTEM WITHIN 10 MINUTES: 224 MG/DL, 113 MG/DL, 316 MG/DL, AND 119 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 ® PERFORMA TEST STRIPS	BLOOD GLUCOSE MONITORING TEST STRIPS	LFR	ROCHE DIAGNOSTICS	NA	321157

Patients

Seq	Age	Sex	Outcome	Treatment
1	070 YR			FUROSEMIDE ONCE DAILY\| CAPTOPRIL EVERY 12 HOURS\| "NPH" INSULIN TWICE DAILY