BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO 29

    MDR report key: 1301348 · Received December 30, 2008

    Report

    Report Number
    2919016-2008-00018
    Event Type
    Malfunction
    Date Received
    December 30, 2008
    Date of Event
    December 9, 2008
    Report Date
    December 9, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LRG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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: ANOTHER TEST PERFORMED BY THE HOSPITAL PROVIDED DISCREPANT RESULTS. CONCLUSIONS: PRODUCT IS WITHIN PERFORMANCE CLAIMS. THE CAUSE OF THE (B) (6) RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED (B) (6) DISCREPANCY, THE HOSPITAL OBTAINED (B) (6) RESULTS ON THE POS COMBO 29 PANEL AND (B) (6) RESULTS WHEN TESTED AGAINST ANOTHER TEST METHOD, ALSO PERFORMED FOR THE CLINICAL ISOLATE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. TREATMENT WAS NOT DELAYED OR WITHHELD. THERE ARE NOT REPORTS OF ADVERSE HEALTH CONSEQUENCES ASSOCIATED WITH THE DISCREPANT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POS COMBO 29 DRIED GRAM POS PANEL LRG SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1