BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA MONITOR

    MDR report key: 372777 · Received January 15, 2002

    Report

    Report Number
    1220459-2002-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2002
    Date of Event
    December 18, 2001
    Report Date
    January 14, 2002
    Manufacturer
    MEDISENSE, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ROUTINE COMPLAINT INVESTIGATION IDENTIFIED A LACK OF PRECISION ISSUE RELATED TO THE USE OF AN INCORRECTLY CALIBRATED METER. IF THIS METER WAS USED TO PERFORM AN ASSAY, THE RESULTS COULD BE AN IMPRECISE READING. NO DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA MONITOR BLOOD GLUCOSE METER CFR MEDISENSE, INC. NA 87733

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other