BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2193592 · Received August 5, 2011

    Report

    Report Number
    3008382007-2011-00159
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Report Date
    July 21, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. THE 510K#: K093745.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH VERIO METER WAS GIVING INACCURATELY LOW READINGS. THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 5.1 MMOL/L ON THE REPORTED METER, AND LABORATORY BLOOD GLUCOSE READING OF 9.0 MMOL/L. THE PATIENT'S TESTING TECHNIQUE WAS CORRECT; THERE WAS NO INFORMATION PROVIDED ABOUT THE PATIENT'S TEST STRIPS. THE PATIENT REPORTED NO SYMPTOMS OR MEDICAL ATTENTION. THE METER WAS REPLACED. AS THE TEST RESULTS FELL OUTSIDE EXPECTED VALUES FOR METER-TO-LABORATORY ACCURACY TESTING THIS COMPLAINT IS BEING REPORTED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3076971

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR