FDA Adverse Event Injury Summary report: N

OT ULTRALINK METER

MDR report key: 1843085 · Received September 23, 2010

Report

Report Number: 2939301-2010-08328
Event Type: Injury
Date Received: September 23, 2010
Date of Event: September 4, 2010
Report Date: September 4, 2010
Manufacturer: LIFESCAN, INC.
Product Code: MDS
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, 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.THE 510K#: 073231.

Description of Event or Problem · 1

ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING THE ERROR 5 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 AT 12:30 PM, THE PATIENT OBTAINED THE ERROR 5 ERROR MESSAGE ON THE REPORTED METER; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. AT 1:45 PM, THE PATIENT EXPERIENCED THE SYMPTOMS OF "HIGH BLOOD GLUCOSE" LEVELS. THE PATIENT TOOK HER USUAL DOSE OF INSULIN USING HER PUMP; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THE PATIENT'S TESTING TECHNIQUE AND TEST STRIPS WERE CORRECT. THE ISSUE WAS RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS OF HYPERGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE AND RECEIVED TREATMENT WITH INSULIN. THEREFORE THIS COMPLAINT IS BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OT ULTRALINK METER	GLUCOSE MONITORING SYS/KIT	MDS	LIFESCAN, INC.		3037493

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Life Threatening