BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2960757 · Received February 14, 2013

    Report

    Report Number
    3008382007-2013-02952
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 21, 2013
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED BUT NOT YET EVALUATED BY LIFESCAN PRODUCT ANALYSIS. LFS WILL EVALUATE IT AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4): THE TEST STRIPS PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED COMPLAINT WAS OBSERVED ON THE METER ERROR LOG, HOWEVER, PA WAS UNABLE TO REPRODUCE FAILURE IN TEST. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, ANOTHER FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THE ONETOUCH VERIO IQ METER READ INACCURATELY COMPARED TO ANOTHER DEVICE. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "7.9 MMOL/L" WITH THE SUBJECT METER AND "4.9 MMOL/L" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION BECAUSE OF THE REPORTED ISSUE. AS THE 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
    65841 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3349831

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR