BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2991939 · Received March 7, 2013

    Report

    Report Number
    3008382007-2013-04339
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE ONETOUCH PING METER READ INACCURATELY ERRATIC. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "317, 99 AND 97 MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. IT WAS ALSO REPORTED THE PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF "102 MG/DL" AND "295 AND 314 MG/DL" AND "266 AND 540 MG/DL" AND "238 MG/DL" AND "211 MG/DL" WITH THE SUBJECT METER. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE RESULTS FELL OUTSIDE EXPECTED VALUES FOR PRECISION TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98117 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3382455

    Patients

    Seq Age Sex Outcome Treatment
    1