BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO 6.1B

    MDR report key: 1278252 · Received November 24, 2008

    Report

    Report Number
    2919016-2008-00015
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    SIEMENS HEALTHCARE DISGNOSTICS INC.
    Product Code
    LRG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE MONITORING OF COMPLAINT HISTORY AND PERFORMANCE TRENDS TO ENSURE PERFORMANCE IS WITHIN CLAIMS. RESULTS: OTHER TESTS PERFORMED BY THE LAB GAVE DIFFERENT RESULTS. CONCLUSIONS: PRODUCT IS WITHIN PERFORMANCE CLAIMS. THE CAUSE OF THE (B) (6) RESULTS IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (B) (6) DISCREPANCY. THE HOSPITAL OBTAINED (B) (6) RESULTS ON THE POS COMBO 6.1B PANEL AND (B) (6) RESULTS WHEN TESTED AGAINST OTHER TEST METHODS ALSO PERFORMED FOR THE CLINICAL ISOLATE. IT IS NOT KNOWN IF THE RESULTS WERE REPORTED TO THE PHYSICIAN OR IF TREATMENT WAS DELAYED OR WITHHELD. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POS COMBO 6.1B DRIED GRAM POS PANEL LRG SIEMENS HEALTHCARE DISGNOSTICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1