BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD COR GX INSTRUMENT

    MDR report key: 16318666 · Received February 8, 2023

    Report

    Report Number
    1119779-2023-00117
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 9, 2023
    Report Date
    March 14, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037/S005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD COR PX INSTRUMENT (CATALOG NUMBER 443990 AND SERIAL NUMBER (B)(6)) HAD A "CONTAMINATION". CUSTOMER REPORTED THAT ON HYPERCARE THAT THEY HAD ICF AND CONTAMINATION. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE CHANGE THE REAGENT KIT BATCHES AND THE ISSUE WAS RESOLVED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR A FAILURE AT INSTALL. DEVICE WAS INSTALLED ON 26MAY2020, AND SINCE THEN OTHER SERVICE ACTIVITIES HAVE OCCURRED, SUCH AS PREVENTATIVE MAINTENANCE AND REPAIR, WHICH HAVE CHANGED THE CONFIGURATION OF THE INSTRUMENT SINCE RELEASE FROM MANUFACTURING. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDER WAS OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. SAMPLES WERE NOT EXPECTED TO BE RETURNED FOR INVESTIGATION, THEREFORE RETURNED SAMPLE ANALYSIS IS NOT PERFORMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. COMPLAINT WAS UNCONFIRMED AS THE ISSUE WAS NOT CAUSED BY THE INSTRUMENT. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD COR GX INSTRUMENT SUSPICIOUS RESULTS OCCURRED AND HAVE BEEN VERIFIED WITH VIPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HYPERCARE FOLLOWING ICF PROBLEM AND CONTAMINATION. WE DIDN¿T FIND ANYTHING UNUSUAL ON THIS KIT. WE DON'T HAVE ANY ERRORS ON RESULT. EVERY SUSPICIOUS RESULT HAS BEEN VERIFIED WITH THE VIPER LT, SO WE ONLY LOST SOME TIME AND REAGENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD COR GX INSTRUMENT SUSPICIOUS RESULTS OCCURRED AND HAVE BEEN VERIFIED WITH VIPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HYPERCARE FOLLOWING ICF PROBLEM AND CONTAMINATION. WE DIDN¿T FIND ANYTHING UNUSUAL ON THIS KIT. WE DON'T HAVE ANY ERRORS ON RESULT. EVERY SUSPICIOUS RESULT HAS BEEN VERIFIED WITH THE VIPER LT, SO WE ONLY LOST SOME TIME AND REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2310074 BD COR GX INSTRUMENT KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS MAQ BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown