FDA Adverse Event Injury Summary report: N

OT ULTRASMART METER

MDR report key: 2082292 · Received May 9, 2011

Report

Report Number: 2939301-2011-03799
Event Type: Injury
Date Received: May 9, 2011
Date of Event: April 28, 2011
Report Date: April 28, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, 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. 510(K) # IS K021819.

Description of Event or Problem · 1

ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HIS ONETOUCH ULTRASMART METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. ABOUT 5 MINUTES AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF SWEATING AND SHAKINESS. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE CCA WAS NOT ABLE TO WALK THE PATIENT THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. 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 ULTRASMART METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN INC.		3121285

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR		Life Threatening