BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 14251402 · Received April 29, 2022

    Report

    Report Number
    1119779-2022-00636
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    April 5, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K014123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 SIRE SUPPLEMENT KIT BATCH 1082145 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 0358713, MGIT 960 STREPTOMYCIN BATCH 1042221, MGIT 960 ISONIAZID BATCH 0366244, MGIT 960 RIFAMPIN BATCH 0366245 AND MGIT 960 ETHAMBUTOL BATCH 0366246. THE BATCH HISTORY RECORD REVIEW FOR THE KIT BATCH WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH FOR PERFORMANCE. MGIT 960 SIRE 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 STANDARD OPERATING PROCEDURES (SOP). ANTIBIOTICS MGIT 960 STREPTOMYCIN, MGIT 960 ISONIAZID, MGIT 960 RIFAMPIN AND MGIT 960 ETHAMBUTOL ARE MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXING 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 SOP. EIGHT MGIT 960 SIRE SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE VIAL OF EACH ANTIBIOTIC TO MAKE A MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). RETENTION SAMPLES MAINTAINED FOR THIS PRODUCT INCLUDE THE INDIVIDUAL COMPONENTS BUT NOT THE KITTED CONFIGURATION, SO RETENTION SAMPLE INSPECTION IS NOT INDICATED FOR THIS COMPLAINT. HOWEVER, RETENTIONS WERE AVAILABLE FOR INSPECTION. STREPTOMYCIN BATCH 1042221 (10 VIALS), ISONIAZID BATCH 0366244 (10 VIALS), RIFAMPIN BATCH 0366245 (10 VIALS), ETHAMBUTOL BATCH 0366246 (10 VIALS), AND GROWTH SUPPLEMENT VIAL BATCH 0358713 (10 VIALS). ALL RETENTION VIALS WERE MAINTAINED IN GOOD CONDITION. THE RETENTIONS WERE PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING OF RETENTIONS TESTED WAS SATISFACTORY PER PROCEDURE FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. NOTES RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISK OF THE DEFECT REPORTED WAS ASSESSED AS SEVERITY S3, PER BALTRMLMBACTECMGITAPH, REV 03, ID 4.11. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SIRE KIT HAS BEEN FOUND SHOWING FALSE RESISTANCE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: RESULTS OF FALSE RESISTANCE TO ALL DRUGS. ALL DRUG RESISTANCE RESULTS WERE OBTAINED FOR SEVERAL SAMPLES. THE RESISTANCE RESULTS ARE NOT CONFIRMED WITH MOLECULAR TESTS. RESISTANCE ALWAYS APPEARS TO ALL DRUGS AND EVEN WHEN IT APPEARS TO BE SENSITIVE THE RESULT IS ALWAYS BORDERLINE. THE CUSTOMER TRIED TO TEST FOR ANY CONTAMINATION BUT THEY TURNED OUT TO BE NEGATIVE. ADDITIONAL INFORMATION FROM TASK: WERE PATIENT SAMPLES INVOLVED? YES. IS A CONFIRMATORY TEST ALWAYS PERFORMED? YES. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? NO.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SIRE KIT HAS BEEN FOUND SHOWING FALSE RESISTANCE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: RESULTS OF FALSE RESISTANCE TO ALL DRUGS. ALL DRUG RESISTANCE RESULTS WERE OBTAINED FOR SEVERAL SAMPLES. THE RESISTANCE RESULTS ARE NOT CONFIRMED WITH MOLECULAR TESTS. RESISTANCE ALWAYS APPEARS TO ALL DRUGS AND EVEN WHEN IT APPEARS TO BE SENSITIVE THE RESULT IS ALWAYS BORDERLINE. THE CUSTOMER TRIED TO TEST FOR ANY CONTAMINATION BUT THEY TURNED OUT TO BE NEGATIVE. ADDITIONAL INFORMATION FROM TASK: WERE PATIENT SAMPLES INVOLVED? YES. IS A CONFIRMATORY TEST ALWAYS PERFORMED? YES. WAS IT OBVIOUS THAT THE RESULTS WERE ERRONEOUS/COULD NOT BE TRUSTED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? NO. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, WAS THERE ANY NEGATIVE IMPACT TO THE PATIENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104990 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 245123 1082145 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown