BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSTREP PLUS TYPE 1 PANELS

    MDR report key: 3888424 · Received April 1, 2014

    Report

    Report Number
    2919016-2014-00016
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LTT
    Removal / Correction Number
    Z-1272-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAD CONDUCTED A FIELD CORRECTION, (B)(4), 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 (B1016-905), 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. ADDITIONALLY ALL SUBSEQUENT LOTS WERE MANUFACTURED WITH UPDATED INFO ON THIS LIMITATION. SIEMENS CONFIRMED THAT THIS CUSTOMER RECEIVED THE INITIAL CUSTOMER NOTIFICATION ASSOCIATED WITH FDA RECALL (B)(4) AND THAT THE LOT WAS MANUFACTURED WITH THE UPDATED INFO (CONFIRMED THROUGH A REVIEW OF THE MANUFACTURING RECORDS).

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT WAS RECEIVED FOR S. AGALACTIAE ISOLATE WITH SUSCEPTIBLE RESULTS FOR ERYTHROMYCIN USING A WALKAWAY BUT VISUALLY THE RESULTS WERE RESISTANT. PANELS WERE VISUALLY VERIFIED AND THE CORRECT "RESISTANT" RESULTS WERE REPORTED TO THE PHYSICIAN. THERE WAS NO ADVERSE IMPACT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194298 MICROSTREP PLUS TYPE 1 PANELS MICROSTREP PLUS TYPE 1 LTT SIEMENS HEALTHCARE DIAGNOSTICS INC. 2014-08-05

    Patients

    Seq Age Sex Outcome Treatment
    1