BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING METER

    MDR report key: 1220760 · Received October 30, 2008

    Report

    Report Number
    2939301-2008-02892
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Report Date
    October 25, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR TEST STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/REPORTER, THE PT'S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH PING METER HAD LINES THROUGH THE DISPLAY. THE PT DID NOT EXPERIENCE ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND DID NOT SEEK ANY MEDICAL ATTENTION. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE CUSTOMER CARE ADVOCATE DETERMINED THE METER HAD SUFFERED NO TRAUMA. THE METER WAS REPLACED. THE PT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PT REPORTED NO SYMPTOMS OR MEDICAL ATTENTION. HOWEVER, AS THE REPORTED METER HAD LINES THROUGH THE DISPLAY, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2852147

    Patients

    Seq Age Sex Outcome Treatment
    1