ACCU-CHEK ® PERFORMA TEST STRIPS

MDR report key: 2842087 · Received November 21, 2012

Report

Report Number: 1823260-2012-05924
Event Type: Injury
Date Received: November 21, 2012
Date of Event: October 25, 2012
Report Date: December 3, 2012
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
PMA / PMN Number: NA
Removal / Correction Number: NA
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6).

Description of Event or Problem · 1

CALLER STATES THE CUSTOMER WAS GIVEN LANTUS BASED ON RESULT OF 153 MG/DL OBTAINED ON THE PERFORMA SYSTEM AT 6:25 AM. AT APPROXIMATELY 6:40 AM, THE CUSTOMER BECAME HYPOGLYCEMIC AND UNCONSCIOUS. CUSTOMER TESTED 45 MG/DL AT 8:12 AM; FIREFIGHTERS WERE CALLED, AND THE CUSTOMER WAS TREATED WITH A BANANA AND LEMON JUICE AT 8:15 AM. CUSTOMER TESTED 309 MG/DL AT 8:39 AM, AND HIS CONDITION IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE.

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	470811

Patients

Seq	Age	Sex	Outcome	Treatment
1	071 YR		Required Intervention	LANTUS