FDA Adverse Event Injury Summary report: N

OT ULTRA TEST STRIPS

MDR report key: 1857241 · Received October 6, 2010

Report

Report Number: 2939301-2010-08859
Event Type: Injury
Date Received: October 6, 2010
Report Date: September 15, 2010
Manufacturer: LIFESCAN, INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, 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 K043197.

Description of Event or Problem · 1

ON (B)(6) 2010, THE LAY USER/REPORTER, THE PATIENT'S WIFE, CONTACTED LIFESCAN TO REPORT THE PATIENT WAS UNABLE TO USE THE ONE TOUCH ULTRA TEST STRIPS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON AN UNSPECIFIED DATE, THE PATIENT CLAIMED HE WAS UNABLE TO UTILIZE HIS NEW TEST STRIPS, AND WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. AFTERWARDS THE PATIENT EXPERIENCED THE SYMPTOM OF SHAKING AND "BOTTOMING OUT". THE PATIENT TOOK THE ACTION OF CONSUMING MORE FOOD AND/OR DRINK; HE DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE PATIENT MANAGES HIS DIABETES WITH THE ORAL MEDICATIONS METFORMIN AND PRANDIN (REPAGLINIDE), AND WITH HUMALOG AND LANTUS INSULIN. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER NOT BEING ABLE TO TEST HIS BLOOD GLUCOSE LEVELS WHILE USING THE REPORTED TEST STRIPS, AND RECEIVED TREATMENT WITH FOOD. THEREFORE THIS COMPLAINT IS BEING REPORTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening