BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 14598348 · Received June 3, 2022

    Report

    Report Number
    1025402-2022-00005
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 9, 2022
    Report Date
    August 5, 2022
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: "MGIT 960 SUPPLEMENT KIT BATCH 2013540 IS COMPOSED OF MGIT PANTA BATCH 2013519 AND MGIT 960 GROWTH SUPPLEMENT BATCH 2013525. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 2013540 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. MGIT PANTA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER SOP. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). THE BATCH HISTORY RECORD REVIEWS FOR MGIT PANTA BATCH 2013519 WAS SATISFACTORY PER INTERNAL PROCEDURES AND MGIT 960 GROWTH SUPPLEMENT BATCH 2013525 WAS SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTIONS FOR PANTA BATCH 2013519 (10 VIALS) AND GROWTH SUPPLEMENT BATCH 2013525 (2 VIALS) WERE AVAILABLE FOR INSPECTION. ALL RETENTION VIALS MAINTAINED HAD NO EVIDENCE OF CONTAMINATION FROM VISUAL INSPECTION. TWO RETENTION PANTA VIALS BATCH 2013519 WERE RECONSTITUTED (PER PROCEDURE) WITH TWO GROWTH SUPPLEMENT VIALS FROM BATCH 2013525. FOR INVESTIGATION OF COMPLAINT, TWO RETENTION PANTA VIALS WERE RECONSTITUTED (PER PROCEDURE) WITH TWO RETENTION GROWTH SUPPLEMENT VIALS FROM BATCH 2013525. ONE RECONSTITUTED PANTA VIAL AND REMAINING GROWTH SUPPLEMENT WERE INCUBATED AT 33-35-DEGREES CELSIUS; AND ONE RECONSTITUTED PANTA AND REMAINING SUPPLEMENT VIAL WERE INCUBATED AT 20-25-DEGREE CELSIUS. AT THE END OF A SEVEN-DAY INCUBATION PERIOD NO MICROBIAL GROWTH WAS OBSERVED. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER BELIEVES MGIT SUPPLEMENT KIT COULD BE INTRODUCING CONTAMINATION OF GORDONIA SP INTO THE MGIT TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. A GRAM STAIN WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED BY THE CUSTOMER THAT CUSTOMER BELIEVES MGIT SUPPLEMENT KIT COULD BE INTRODUCING CONTAMINATION OF GORDONIA SP INTO THE MGIT TUBES. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031672 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT SYSTEM, BLOOD CULTURING MDB LEE LABORATORIES, INC. 245124 2013540 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown