BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1071027 · Received July 2, 2008

    Report

    Report Number
    2939301-2008-01278
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Report Date
    June 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT TEST STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE TEST STRIPS ARE 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/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS READING INACCURATELY HIGH WITH CONTROL SOLUTION. THE PATIENT REPORTED A CONTROL SOLUTION TEST RESULT OF "126 MG/DL" WITH A CONTROL SOLUTION RANGE OF "94-125 MG/DL." THE CUSTOMER CARE ADVOCATE WALKED THE LAY USER THROUGH A CONTROL SOLUTION TEST WITH A NEW VIAL OF TEST STRIPS AND THE RESULTS FELL WITHIN THE SPECIFIED CONTROL SOLUTION RANGE. THERE WAS 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 2808580

    Patients

    Seq Age Sex Outcome Treatment
    1 Female