BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2232926 · Received September 2, 2011

    Report

    Report Number
    3008382007-2011-00311
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 24, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 510 (K) # IS K093745.

    Description of Event or Problem · 1

    THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "20.8 MMOL/L" WITH A LIFESCAN METER AND "15.2 MMOL/L" 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 <=30%. THERE WAS NO ALLEGATION OF HARM OR INJURY BECAUSE OF THE REPORTED ISSUE. THE METER WAS REPLACED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR