BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTHER SYSTEM

    MDR report key: 6378241 · Received March 3, 2017

    Report

    Report Number
    2024800-2017-00009
    Event Type
    Malfunction
    Date Received
    March 3, 2017
    Date of Event
    January 10, 2017
    Report Date
    March 3, 2017
    Manufacturer
    HOLOGIC, INC.
    Product Code
    MKZ
    PMA / PMN Number
    K111409
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT: DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE BARCODE SCANNER RETURNED FROM JRC HAD BOTH CODABAR 4-25 AS WELL AS CODABAR 11 PROGRAMMED INTO THE BARCODE SYMBOLOGY SETTINGS. FIELD SERVICE BULLETIN FS-325, USED BY GRIFOLS FSE TO INSTALL, INSTRUCTS THE FSE TO PROGRAM CODABAR 11 BUT DOES NOT EXPLICITLY STATE THAT THE CODABAR 4-25 NEEDS TO BE REMOVED OR NOT PROGRAMMED AT ALL. FURTHER INVESTIGATION FROM SUPPLIER REVEALED A CODING BUG IN THE SOFTWARE THAT BARCODES CAN CONCATENATE AND PRODUCE LONGER THAN EXPECTED AND INCORRECT BARCODES; PARTICULARLY SINCE THE BARCODE HAD BOTH CODABAR11 AND CODABAR 4-25. IF ONLY ONE SYMBOLOGY WAS INSTALLED, THEN THE MISREAD WOULD NOT HAVE OCCURRED. AS A CORRECTIVE ACTION, FS-325 BULLETIN WILL BE REVISED TO EXPLICITLY STATE ONE BARCODE SYMBOLOGY BEING PROGRAMMED INTO THE SCANNER. AS FURTHER MITIGATION INTO THIS ISSUE, HOLOGIC WILL FIX IN THE NEXT REVISION OF SOFTWARE VERSION 7.0. THIS SOFTWARE WILL NOT BE AVAILABLE UNTIL END OF 2018 OR EARLY 2019, BASED ON THE CURRENT DEVELOPMENT SCHEDULE.

    Description of Event or Problem · 1

    GRIFOLS' CUSTOMER, (B)(6) REPORTED DURING AN ULTRIO ELITE ASSAY RUN, THAT SAMPLE (B)(6) WAS MISREAD AS (B)(6) BY THE PANTHER INSTRUMENT. CUSTOMER IDENTIFIED THIS ISSUE WHEN THE LABORATORY INFORMATION SYSTEM (LIS) DID NOT HAVE A RESULT FOR THE SAMPLE (B)(6). AT THAT TIME, THEY DISCOVERED THE PANTHER INSTRUMENT MISREAD AS (B)(6). THE NUMBER CREATED BY THE PANTHER DID NOT EXIST IN SITE AS A DONOR SYSTEM RECORD. NO INCORRECT RESULT WAS REPORTED OUT. HOLOGIC SW TEAM CONFIRMED THE ISSUE WAS NOT SOFTWARE RELATED BUT A POSSIBLE FIRMWARE ISSUE. PANTHER SUPPLIER WAS NOTIFIED AND FURTHER INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158302 PANTHER SYSTEM IN VITRO DIAGNOSTICS MKZ HOLOGIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention