FDA Adverse Event Injury Summary report: N

OT ULTRAMINI METER

MDR report key: 2543512 · Received April 20, 2012

Report

Report Number: 2939301-2012-03891
Event Type: Injury
Date Received: April 20, 2012
Date of Event: April 7, 2012
Report Date: April 9, 2012
Manufacturer: LIFESCAN INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.THE 510(K) # IS K061118.

Description of Event or Problem · 1

ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER POWERS OFF DURING USE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS (AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE. AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF BLURRED VISION, SWEATS AND RAPID HEARTBEAT. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO INDICATION OF MISUSE. THE PATIENT EDUCATED THE PATIENT ON THE METER'S BEHAVIOR AND AUTOMATIC SHUTOFF FEATURE TO RESOLVE THE ALLEGED ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRAMINI METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN INC.		3241279

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Life Threatening