BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2860942 · Received December 6, 2012

    Report

    Report Number
    3008382007-2012-07355
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Report Date
    November 20, 2012
    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
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS REPLACED AND REQUESTED BACK.

    Description of Event or Problem · 1

    THE LAY USER / PATIENT CONTACTED LFS ALLEGING INACCURATE READINGS COMPARED TO ANOTHER METER. THE PATIENT MENTIONED THAT THEY COMPARED THEIR ONE TOUCH PING METER TO THE PHYSICIAN'S METER AND THAT THERE WAS A 100 POINTS DIFFERENCE BETWEEN THE TWO READINGS. RESULTS ON BOTH DEVICES WERE NOT PROVIDED. READINGS WERE DONE LESS THAN 30 MINUTES FROM ONE ANOTHER. THE PATIENT MENTIONED 30 MINUTES BEFORE TESTING THEY WERE NOT FEELING WELL. THE PATIENT DENIED RECEIVING ANY MEDICAL TREATMENT DUE TO THE ALLEGED ISSUE. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE PRODUCT WAS REPLACED. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT SINCE THE PATIENT'S SYMPTOMS ARE NOT SUGGESTIVE OF A SERIOUS INJURY AND HAD DEVELOPED SYMPTOMS 30 MINUTES BEFORE TESTING. THE COMPLAINT IS BEING REPORTED SINCE THE PATIENT CLAIMS THAT THERE WAS A 100 POINTS DIFFERENCE BETWEEN THEIR PING METER AND THE PHYSICIAN'S METER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR