FDA Adverse Event Injury Summary report: N

OT SELECT METER

MDR report key: 2356199 · Received December 2, 2011

Report

Report Number: 2939301-2011-11802
Event Type: Injury
Date Received: December 2, 2011
Date of Event: November 30, 2011
Report Date: November 30, 2011
Manufacturer: LIFESCAN INC.
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SF
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. THE 510K#: K072543.

Description of Event or Problem · 1

ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH SELECT METER WAS GIVING THE ERROR 2 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON (B)(6) 2011, THE PATIENT OBTAINED THE ERROR MESSAGE ERROR 2 ON THE REPORTED METER; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT REPORTED THAT SHE DELAYED TAKING HER USUAL DIABETES MEDICATIONS METFORMIN 850 MG/DL AND LEVEMIR INSULIN 20 UNITS. ON THE MORNING OF (B)(6) 2011 THE PATIENT EXPERIENCED THE SYMPTOMS OF DIZZINESS, RAPID HEARTBEAT AND NAUSEA. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVELS DUE TO THE METER ISSUE. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR		Life Threatening