BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFAST 5J

    MDR report key: 3704707 · Received January 17, 2014

    Report

    Report Number
    2919016-2014-00006
    Event Type
    Malfunction
    Date Received
    January 17, 2014
    Date of Event
    August 24, 2012
    Report Date
    September 14, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LRG
    Removal / Correction Number
    Z-1272-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - USE TESTING: THE ISOLATE WAS TESTED AT MICROSCAN USING MICROFAST 7J PANEL. RESULTS - INCORRECT DATA DEFINITION - DISCREPANT RESULTS WERE NOT CONFIRMED. CONCLUSION - DESIGN DEFICIENCY - THE MICROSCAN TESTING DID NOT CONFIRM THE MISREADS.

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED FOR (B)(4) S. AGALACTIAE ISOLATE WITH MULTIPLE ANTIBIOTIC MISREADS. SEE MDRS 2919016-2014-00001 THROUGH 2919016-2014-00007. INITIAL TESTING DID NOT CONFIRM THE CUSTOMER RESULTS, BUT ON RETEST THE RESULTS WERE DUPLICATED. IT IS UNK IF THE PATIENTS WERE TREATED BASED ON THE DISCREPANT RESULTS OR IF THERE WAS A DELAY IN TREATMENT. SIEMENS CONDUCTED THE FIELD CORRECTION, (B)(4), FDA NUMBER Z-1272-2013 ON 03/06/2013, FOR FALSE SKIPPED WELLS AND FALSE SUSCEPTIBLE MISREADS WITH S. AGALACTIAE AFFECTING MULTIPLE ANTIMICROBIAL AGENTS ON MICROSCAN MICROSTREP PLUS TYPE 1 PANELS (B1027-201), MICROSTREP PLUS TYPE 5 PANELS (B1016-95), MICROFAST TYPE 5J PANELS (J1016-83) AND MICROFAST TYPE 7J PANELS (J1016-84). THE CUSTOMER LETTER STATED RESULTS SHOULD BE VISUALLY VERIFIED FOR S. AGALACTIAE ISOLATES ON THE ABOVE PANEL TYPES. A REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FIELD CORRECTION DETERMINED A MDR WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46077 MICROFAST 5J MICROFAST 5J LRG SIEMENS HEALTHCARE DIAGNOSTICS INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1