BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POINTE SCIENTIFIC, INC. GLUCOSE HEXOKINASE HITACHI REAGENT

    MDR report key: 1252083 · Received December 8, 2008

    Report

    Report Number
    1827821-2008-00001
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Report Date
    September 5, 2008
    Manufacturer
    POINTE SCIENTIFIC, INC.
    Product Code
    CFR
    PMA / PMN Number
    K002199
    Removal / Correction Number
    1827821-9/10/08-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO FIELD EVENTS REPORTED. MDR FILED BASED ON POTENTIAL FIELD RISK FOR MIS-REPORTING OF PATIENT RESULTS.

    Description of Event or Problem · 1

    REAGENT FAILING TO MAINTAIN PERFORMANCE SPECIFICATIONS, SPECIFICALLY LINEARITY CLAIMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POINTE SCIENTIFIC, INC. GLUCOSE HEXOKINASE HITACHI REAGENT GLUCOSE HEXOKINASE REAGENT CFR POINTE SCIENTIFIC, INC. 725701

    Patients

    Seq Age Sex Outcome Treatment
    1