FDA Adverse Event Injury Summary report: N

OT ULTRA METER

MDR report key: 2873249 · Received December 13, 2012

Report

Report Number: 3008382007-2012-08097
Event Type: Injury
Date Received: December 13, 2012
Date of Event: November 21, 2012
Report Date: December 6, 2012
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
PMA / PMN Number: K062195
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, 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.

Description of Event or Problem · 1

ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2012. THE PATIENT MANAGES HER DIABETES WITH HUMALOG INSULIN (SLIDING SCALE) AND LANTUS INSULIN (15 UNITS AT NIGHT). THE PATIENT REPORTEDLY CONTINUED TO TAKE HER USUAL DOSE OF MEDICATIONS. ABOUT 5-10 MINUTES AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMS HER HANDS WERE TINGLING AND SHE FELT SHAKY. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. THE CCA NOTED MISUSE SINCE THE SUBJECT METER WAS DROPPED IN WATER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRA METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3381092

Patients

Seq	Age	Sex	Outcome	Treatment
1	38 YR		Life Threatening