FDA Adverse Event Injury Summary report: N

OT ULTRAMINI

MDR report key: 1801473 · Received August 16, 2010

Report

Report Number: 2939301-2010-06645
Event Type: Injury
Date Received: August 16, 2010
Date of Event: August 2, 2010
Report Date: August 2, 2010
Manufacturer: LIFESCAN, INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SC, 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) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED POWER ISSUE STARTED ON (B)(6) 2010 AT 9:00AM. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE; HOWEVER, REPORTED FEELING SWEATY AND SHAKY ½ HOUR LATER. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS UNABLE TO CONFIRM THE ALLEGED POWER ISSUE. THE SUBJECT METER POWERED ON MANUALLY AND WHEN A TEST STRIP WAS INSERTED. THE ALLEGED POWER ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRAMINI	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN, INC.		2986514

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Life Threatening