BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 1792032 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06414
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Product Problem
    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.

    Description of Event or Problem · 1

    ON JULY 27, 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRALINK METER WAS GIVING THE ERROR 1 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON (B)(6) 2010 AT 11:00 PM, WHILE IN (B)(6), THE PATIENT OBTAINED THE ERROR 1 ERROR MESSAGE ON THE REPORTED METER; HE DID NOT OBTAIN A BLOOD GLUCOSE READING. THE PATIENT EXPERIENCED THE SYMPTOM OF "HIGH BLOOD SUGAR", AND TOOK THE ACTION OF CONSUMING LESS FOOD. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR TREATMENT. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT DID NOT REPORT ANY SYMPTOMS INDICATING SEVERE INJURY, AND HE DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE METER ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3020286

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR