BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3161236 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16465
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    June 6, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2013-IE-017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ON (B)(6) 2013 ALLEGING THE METER PRODUCES AN INACCURATELY HIGH READING COMPARED TO ANOTHER DEVICE. THE LFS METER WAS READING "168MG/DL" COMPARED TO "106MG/DL" ON AN UNKNOWN METER WITHIN 30 MINUTES OF EACH OTHER. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSION: BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THE RESULTS EXCEEDS THE EXPECTED VALUE OF <=30% DIFFERENCE FOR READINGS ABOVE 75MG/DL TAKEN WITHIN 30 MINUTES OF ONE ANOTHER. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT AND NO ALLEGATIONS OF HARM OR INJURY WERE MADE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262903 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1