ACCU-CHEK ® COMPACT TEST DRUM

MDR report key: 3910648 · Received July 2, 2014

Report

Report Number: 1823260-2014-04860
Event Type: Malfunction
Date Received: July 2, 2014
Date of Event: May 15, 2014
Report Date: July 2, 2014
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

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6). DEVICE WILL NOT BE RETURNED.

Description of Event or Problem · 1

REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 1.2 MMOL/L AND 5.7 MMOL/L. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION; HOWEVER, THE SUSPECT STRIPS ARE NO LONGER AVAILABLE AND WILL NOT BE RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
388226	ACCU-CHEK ® COMPACT TEST DRUM	BLOOD GLUCOSE MONITORING TEST STRIPS	LFR	ROCHE DIAGNOSTICS	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	077 YR