FDA Adverse Event Injury Summary report: N

OT ULTRA METER

MDR report key: 2304003 · Received October 21, 2011

Report

Report Number: 2939301-2011-10449
Event Type: Injury
Date Received: October 21, 2011
Date of Event: October 15, 2011
Report Date: October 18, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GR
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. (B)(6). THE 510K#:K001109.

Description of Event or Problem · 1

ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WAS POWERING OFF DURING USE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011 AT 5:30 AM, THE PATIENT NOTED THE REPORTED METER WOULD POWER OFF DURING THE TEST; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. TWO DAYS AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOM OF FREQUENT URINATION. DURING THIS TIME PERIOD, THE PATIENT TOOK HIS USUAL DOSE OF THE ORAL DIABETES MEDICATION SOLOZA (GLIMEPIRIDE) 4 MG. HE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT HAD REPLACED THE BATTERY RECENTLY WITH THE CORRECT BATTERY. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL DUE TO THE METER POWER ISSUE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Life Threatening