BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2868348 · Received December 11, 2012

    Report

    Report Number
    3008382007-2012-07845
    Event Type
    Malfunction
    Date Received
    December 11, 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
    IT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510 (K) K110637.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LFS (B)(4) ALLEGING INACCURATE READINGS ON THEIR LFS METER. THE PATIENT MENTIONED THAT THEY OBTAINED A BLOOD GLUCOSE READING OF 247 MG/DL, 147 MG/DL AND 142 MG/DL WITHIN 20 MINUTES FROM ONE ANOTHER. THE PATIENT DENIED EXHIBITING ANY SYMPTOMS OR SEEKING ANY MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. THE TEST STRIP VIAL WAS NOT CRACKED OR BROKEN. THE COMPLAINT IS BEING REPORTED SINCE THE RESULTS ARE GREATER THAN 20% OR 20 MG/DL.

    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 3242932

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR