BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2771206 · Received October 3, 2012

    Report

    Report Number
    3008382007-2012-04747
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Report Date
    September 27, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH VERIO PRO WAS GIVING INACCURATELY HIGH READINGS COMPARED TO ANOTHER METER. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 14.5 MMOL/L ON THE REPORTED METER, AND A READING OF 10.9 MMOL/L ON ANOTHER MANUFACTURER'S METER WITHIN 30 MINUTES. THE PATIENT DID NOT SUFFER ANY INJURY DUE TO THIS ISSUE. AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER-TO-METER ACCURACY TESTING, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3322531

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR