BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2960738 · Received February 14, 2013

    Report

    Report Number
    3008382007-2013-02989
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 22, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER AND TEST STRIPS PASSED ALL TESTING. THE PRIMARY ISSUE COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. DEVICE RETURNED TO MFG DATE: METER- 2/26/2013, TEST STRIPS- 2/26/2013.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULTS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "64 MG/DL" WITH A LIFESCAN METER AND "87 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF(B)(4). THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN'S ACCURACY/PRECISION CRITERIA AND THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPORTEDLY, THE PATIENT HAD SYMPTOMS DESCRIBED AS "CONFUSING AND DISORIENTED" TWO HOURS PRIOR TO THE ONSET OF THE INACCURACY ISSUE. THERE WAS NO REPORTED MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65084 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3404976

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR