BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1051986 · Received May 22, 2008

    Report

    Report Number
    2939301-2008-00841
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER / PT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS PROMPTING THE ERROR 5 MESSAGE. SHE STATED THAT SHE HAD TRIED TESTING HER METER WITH FOUR DIFFERENT VIALS OF TEST STRIPS FROM THE SAME BOX AND STILL GETS AN ERROR 5 MESSAGE. THE PT DOES NOT HAVE METER OR TEST STRIPS WITH HER TO GO THROUGH TROUBLESHOOTING WITH THE CUSTOMER SVC ADVOCATE AT THE TIME OF THE CALL. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1