BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POINTE SCIENTIFC, INC LIQUID GLUCOSE REAGENT

    MDR report key: 1498973 · Received September 10, 2009

    Report

    Report Number
    1827821-2009-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2009
    Report Date
    August 12, 2009
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Product Code
    CFR
    PMA / PMN Number
    K971754
    Removal / Correction Number
    1827821-8/27/09-009-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER INDICATED THAT PERFORMANCE FAILURE OF DEVICE DID NOT RESULT IN PT RESULTS BEING REPORTED; HOWEVER, UNDER CERTAIN CONDITIONS, IF THE MALFUNCTION WAS REPEATED, IT MAY BE POSSIBLE THAT INACCURATE RESULTS MAY BE GENERATED. (B)(4)

    Description of Event or Problem · 1

    COMPLAINT INDICATED LOSS OF LINEARITY AT >200MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POINTE SCIENTIFC, INC LIQUID GLUCOSE REAGENT LIQUID GLUCOSE HEX REAGENT CFR POINTE SCIENTIFIC, INC. 826801

    Patients

    Seq Age Sex Outcome Treatment
    1