BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 8815130 · Received July 23, 2019

    Report

    Report Number
    3008382007-2019-02997
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    July 20, 2019
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY ERRATIC. THE REPORTER CLAIMED THAT THEY PERFORMED THREE PRECISION COMPARISONS WITH THE SUBJECT METER, OBTAINING THREE SETS OF BLOOD GLUCOSE READINGS, WHICH WERE ¿200, 120 AND 110 MG/DL¿, "160, 140 AND 110 MG/DL" AND "191, 212, 120 AND 113 MG/DL". THE RESULTS IN EACH COMPARISON WERE OBTAINED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR PRECISION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609461 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 4506538

    Patients

    Seq Age Sex Outcome Treatment
    1