BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1051978 · Received May 22, 2008

    Report

    Report Number
    2939301-2008-00890
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 19, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE STRIPS DO 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 READING INACCURATELY HIGH WHEN A CONTROL SOLUTION TEST WAS DONE. THE CUSTOMER CARE ADVOCATE WALKED THE LAY USER THROUGH CONTROL SOLUTION TEST AND THE RESULTS FELL INSIDE THE SPECIFIED CONTROL SOLUTION RANGE. THE PT'S TEST STRIPS WERE REPLACED. 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 2797679

    Patients

    Seq Age Sex Outcome Treatment
    1 Female