BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POS COMBO 20

    MDR report key: 1278250 · Received November 24, 2008

    Report

    Report Number
    2919016-2008-00013
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTIC INC.
    Product Code
    LRG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. DISCREPANT RESULTS WHEN PANEL WAS READ MANUALLY. CONCLUSIONS: THE CAUSE OF THE OXACILLIN SUSCEPTIBLE RESULTS IS UNK.

    Description of Event or Problem · 1

    CUSTOMER REPORTED S. AUREUS ISOLATES OXACILLIN (OX) MIC DISCREPANCY. THE HOSPITAL OBTAINED OXACILLIN-SUSCEPTIBLE RESULTS ON THE POST COMBP 20 AND OXACILLIN-RESISTANT RESULTS WHEN VISUALLY VERIFIED FOR THE CLINICAL ISOLATE. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN. TREATMENT WAS NOT DELAYED OR WITHHELD. THERE WAS 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 20 DRIED GRAM POS PANEL LRG SIEMENS HEALTHCARE DIAGNOSTIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1