BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROCHE

    MDR report key: 436582 · Received December 4, 2002

    Report

    Report Number
    436582
    Event Type
    Other
    Date Received
    December 4, 2002
    Date of Event
    November 25, 2002
    Report Date
    December 2, 2002
    Manufacturer
    ROCHE DIAGNOSTICS CORP
    Product Code
    CFR
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSING UNIT NOTED ELEVATED GLUCOSE READINGS ON FINGERSTICK. PROBLEM OCCURRED WITH ROCHE TEST STRIPS AND WAS SPORADIC. LOTS TESTED AND 10 INSTANCES IDENTIFIED WHERE STRIPS TESTED 100-150 MG/DL HIGHER THAN STATED-GAVE FAIL READING UPON TESTING CONTROL. ROCHE CONTACTED AND ALL AFFECTED STRIPS FROM LOT HAVE BEEN REMOVED FROM USE. ALSO COLLECTED FROM PRACTICE SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE GLUCOSE COMFORT CURVE STRIPS CFR ROCHE DIAGNOSTICS CORP * 545969

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other