BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 CALIBRATOR KIT

    MDR report key: 13994210 · Received April 4, 2022

    Report

    Report Number
    1119779-2022-00498
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 7, 2022
    Report Date
    August 12, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: B5. IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 CALIBRATOR KIT PRODUCED 59 FALSE POSITIVE RESULTS. AFTER VISUAL INSPECTION, THE TUBES WERE RETURNED TO THE INSTRUMENT FOR FURTHER TESTING, WITH ALL RETURNING NEGATIVE. CONFIRMATORY SMEAR AND SUBCULTURE TESTING WAS ALSO PERFORMED WITH NEGATIVE RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS, AND THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN URGENT PROBLEM WITH MGIT. WE RECENTLY DID THE CALIBRATION OF THE MGIT INSTRUMENT AND AFTER CALIBRATION WE GET A LOT OF FALSE POSITIVE RESULTS." "CLINICAL SAMPLES INVOLVED, NO FALSE RESULTS REPORTED AS THE CUSTOMER CHECKS THE TUBES VISUALLY AND CAN SEE THEY WERE NOT POSITIVE. NO TREATMENT FOR PATIENTS WITH FALSE RESULTS. ALL TUBES IN ROWS C, D, E AND MOST TUBES IN ROW H WERE FLAGGED POSITIVE (59 TUBES)." "THE INSTRUMENT IS WORKING AS INTENDED. THE CUSTOMER MANUALLY CHECKED THE TUBES WHICH WERE FLAGGED POSITIVE COULD NOT CONFIRM THE PRESENCE OF ORGANISMS. THE CUSTOMER COULD FOLLOW THE PROCESS FOR RETURNING FALSE POSITIVES TO THE INSTRUMENT FOR FURTHER TESTING. FOLLOWING THIS, THEY DID NOT ENCOUNTER MORE FALSE POSITIVE RESULTS." "YES, WE PERFORMED AFB SMEAR (ZHIEL-NEELSEN STAINING) FOR ALL FALSE POSITIVE MGIT CULTURES AND IDENTIFICATION (MPB64, CAPILIA-TB-NEO), PLUS CULTURE ON BLOOD AGAR (TO RULE OUT POSSIBLE CONTAMINATION). ALL SMEAR NEGATIVE AND ID NEGATIVE VIALS ARE SUBCULTURED ON SOLID L-J MEDIA. EVEN WEEKLY NEGATIVE CONTROL WAS FALSE POSITIVE. NO ERRONEOUS RESULTS WERE PROVIDED TO THE CLINICIANS." H6. INVESTIGATION SUMMARY: MATERIAL 445999 IS MANUFACTURED BY THE TUBES BEING FILLED, CAPPED, TORQUED, AND THEN LABELED BY MACHINE PER STANDARD OPERATING PROCEDURE (SOP). THE TUBES ARE PACKAGED INTO FINAL SHIPPING CONFIGURATIONS. THE BATCH HISTORY RECORD REVIEW FOR BATCH 1349621 WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. FILLING AND PACKAGING PROCESSES WERE WITHIN SPECIFICATIONS. IN PROCESS CHECKS WERE PERFORMED DURING MANUFACTURING AT DESIGNATED INTERVALS PER PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH. RETENTION SAMPLES FROM BATCH 1349621 (51 TUBES) WERE AVAILABLE FOR INSPECTION. NO DEFECTS WERE OBSERVED IN 51/51 RETENTION SAMPLES. THE RETENTION SAMPLES WERE TESTED FOR QC TESTING. THE CALIBRATOR PERFORMANCE TESTED SATISFACTORY. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 CALIBRATOR KIT PRODUCED 59 FALSE POSITIVE RESULTS. AFTER VISUAL INSPECTION, THE TUBES WERE RETURNED TO THE INSTRUMENT FOR FURTHER TESTING, WITH ALL RETURNING NEGATIVE. THE ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS, AND THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN URGENT PROBLEM WITH MGIT. WE RECENTLY DID THE CALIBRATION OF THE MGIT INSTRUMENT AND AFTER CALIBRATION WE GET A LOT OF FALSE POSITIVE RESULTS." "CLINICAL SAMPLES INVOLVED, NO FALSE RESULTS REPORTED AS THE CUSTOMER CHECKS THE TUBES VISUALLY AND CAN SEE THEY WERE NOT POSITIVE. NO TREATMENT FOR PATIENTS WITH FALSE RESULTS. ALL TUBES IN ROWS C, D, E AND MOST TUBES IN ROW H WERE FLAGGED POSITIVE (59 TUBES)." "THE INSTRUMENT IS WORKING AS INTENDED. THE CUSTOMER MANUALLY CHECKED THE TUBES WHICH WERE FLAGGED POSITIVE COULD NOT CONFIRM THE PRESENCE OF ORGANISMS. THE CUSTOMER COULD FOLLOW THE PROCESS FOR RETURNING FALSE POSITIVES TO THE INSTRUMENT FOR FURTHER TESTING. FOLLOWING THIS, THEY DID NOT ENCOUNTER MORE FALSE POSITIVE RESULTS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 CALIBRATOR KIT PRODUCED 59 FALSE POSITIVE RESULTS. AFTER VISUAL INSPECTION, THE TUBES WERE RETURNED TO THE INSTRUMENT FOR FURTHER TESTING, WITH ALL RETURNING NEGATIVE. CONFIRMATORY SMEAR AND SUBCULTURE TESTING WAS ALSO PERFORMED WITH NEGATIVE RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS, AND THERE WAS NO ADVERSE PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE AN URGENT PROBLEM WITH MGIT. WE RECENTLY DID THE CALIBRATION OF THE MGIT INSTRUMENT AND AFTER CALIBRATION WE GET A LOT OF FALSE POSITIVE RESULTS." "CLINICAL SAMPLES INVOLVED, NO FALSE RESULTS REPORTED AS THE CUSTOMER CHECKS THE TUBES VISUALLY AND CAN SEE THEY WERE NOT POSITIVE. NO TREATMENT FOR PATIENTS WITH FALSE RESULTS. ALL TUBES IN ROWS C, D, E AND MOST TUBES IN ROW H WERE FLAGGED POSITIVE (59 TUBES)." "THE INSTRUMENT IS WORKING AS INTENDED. THE CUSTOMER MANUALLY CHECKED THE TUBES WHICH WERE FLAGGED POSITIVE COULD NOT CONFIRM THE PRESENCE OF ORGANISMS. THE CUSTOMER COULD FOLLOW THE PROCESS FOR RETURNING FALSE POSITIVES TO THE INSTRUMENT FOR FURTHER TESTING. FOLLOWING THIS, THEY DID NOT ENCOUNTER MORE FALSE POSITIVE RESULTS." "YES, WE PERFORMED AFB SMEAR (ZHIEL-NEELSEN STAINING) FOR ALL FALSE POSITIVE MGIT CULTURES AND IDENTIFICATION (MPB64, CAPILIA-TB-NEO), PLUS CULTURE ON BLOOD AGAR (TO RULE OUT POSSIBLE CONTAMINATION). ALL SMEAR NEGATIVE AND ID NEGATIVE VIALS ARE SUBCULTURED ON SOLID L-J MEDIA. EVEN WEEKLY NEGATIVE CONTROL WAS FALSE POSITIVE. NO ERRONEOUS RESULTS WERE PROVIDED TO THE CLINICIANS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620513 BD BACTEC¿ MGIT¿ 960 CALIBRATOR KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 1349621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown