BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2874952 · Received December 16, 2012

    Report

    Report Number
    3008382007-2012-08315
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Report Date
    November 29, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012 THE LAY USER/PATIENT CONTACTED LIFESCAN FROM THE UNITED STATES ALLEGING THAT THEIR ONETOUCH VERIO IQ METER WAS READING INACCURATELY ERRATIC WHEN PERFORMING BACK TO BACK BLOOD GLUCOSE TESTS. THE PATIENT CLAIMED THAT THEY OBTAINED BLOOD GLUCOSE RESULTS OF "160 AND 120 MG/DL" WITH THE SUBJECT METER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF (B)(4). THE PATIENT DENIED DEVELOPING SYMPTOMS OR RECEIVING MEDICAL INTERVENTION DUE TO THE ALLEGED ISSUE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING AND REPLACEMENT PRODUCT WAS SENT TO THE PATIENT. THE COMPLAINT IS BEING RULED OUT AS AN ADVERSE EVENT BECAUSE THE PATIENT DID NOT ALLEGE ANY HARM DUE TO THE ALLEGED ISSUE. HOWEVER, THEIR COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE TWO RESULTS BEING COMPARED EXCEED LIFESCAN'S SPECIFICATIONS FOR PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3248156

    Patients

    Seq Age Sex Outcome Treatment
    1