BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 3162738 · Received June 11, 2013

    Report

    Report Number
    3008382007-2013-16673
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 22, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THEIR ONETOUCH VERIO METER READ INACCURATELY ERRATIC. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF ¿16.2 AND 4.7MMOL/L¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON CONSENSUS ERROR GRID ANALYSIS, THE DIFFERENCE BETWEEN THESE RESULTS FALLS WITHIN THE D ZONE THEREFORE THIS COMPLAINT IS DEEMED REPORTABLE. THE PATIENT DOES NOT HAVE CONTROL SOLUTION FOR TROUBLESHOOTING. THE PATIENT WAS SENT REPLACEMENT PRODUCTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT PERFORMED A METER-TO-SAME METER COMPARISON WHERE THE RESULTS FROM PRECISION TESTING FELL WITHIN THE D ZONE ON THE CONSENSUS ERROR GRID. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT REPORT ANY SYMPTOMS OR TREATMENT AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262330 OT VERIO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3382776

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR