BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1071037 · Received July 2, 2008

    Report

    Report Number
    2939301-2008-01309
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Report Date
    June 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT/LAYPERSON INFORMED A CUSTOMER CARE ADVOCATE, CCA, THAT HIS ONETOUCH ULTRALINK METER PROMPTED ERROR 5. BECAUSE THE PATIENT DID NOT HAVE ANOTHER VIAL OF TEST STRIPS, THE CCA WAS UNABLE TO RESOLVE THE ALLEGED ISSUE. THE CCA REPLACED THE METER AND THE TEST STRIPS. THE PATIENT HAD NO SYMPTOMS NOR RECEIVED MEDICAL INTERVENTION DUE TO THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2829483

    Patients

    Seq Age Sex Outcome Treatment
    1