BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 17121253 · Received June 13, 2023

    Report

    Report Number
    1119779-2023-00647
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 21, 2023
    Report Date
    August 29, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED: D4. MEDICAL DEVICE LOT #: 2111285, D4. MEDICAL DEVICE EXPIRATION DATE: 28-JUL-2023, H4. DEVICE MANUFACTURE DATE: 21-APR-2022.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MGIT 960 SIRE SUPPLEMENT KIT BATCH 2111285 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 2060389, MGIT 960 STREPTOMYCIN BATCH 2056967, MGIT 960 ISONIAZID BATCH 2056968, MGIT 960 RIFAMPIN BATCH 2056972 AND MGIT 960 ETHAMBUTOL BATCH 2025711. THE BATCH HISTORY RECORD REVIEW FOR THE KIT BATCH WAS SATISFACTORY AND NO QUALITY NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND ONE OTHER COMPLAINT HAS BEEN TAKEN ON THIS KIT BATCH FOR A PERFORMANCE ISSUE. 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, HOWEVER, RETENTIONS WERE AVAILABLE FOR INSPECTION: STREPTOMYCIN BATCH 2056967 (10 VIALS), ISONIAZID BATCH 2056968 (10 VIALS), RIFAMPIN BATCH 2056972 (10 VIALS: ETHAMBUTOL BATCH 2025711 (10 VIALS), AND SIRE SUPPLEMENT (6 VIALS). THE RETENTIONS WERE PERFORMANCE TESTED FOR ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER QC PROCEDURE AND ANTIBIOTIC SUSCEPTIBILITY. THE POTENCY OF THE ETHAMBUTOL ANTIBIOTIC WAS SATISFACTORY PER QC PROCEDURES AND IN ACCORDANCE WITH THE CERTIFICATE OF ANALYSIS TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: BOTH PHOTOS SHOW SOME 7ML MGIT TUBES FROM BATCH 2103012. THERE APPEARS TO BE WHITE FOREIGN MATERIAL TOWARDS THE SENSOR OF A FEW OF THE TUBES. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THE RETENTIONS WERE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTING WAS SATISFACTORY PER QC PROCEDURES FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. TO ADDRESS THE CUSTOMER¿S CONCERN THE ETHAMBUTOL PERFORMED AS EXPECTED AND IN ACCORDANCE WITH THE CERTIFICATE OF ANALYSIS. THIS COMPLAINT CANNOT BE CONFIRMED BASED ON THE PERFORMANCE OF THE RETENTION SAMPLES. NO COMPLAINT TRENDS FOR THIS DEFECT HAS BEEN IDENTIFIED FOR THIS PRODUCT; NO ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE ISSUES.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K003062; K014123. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: THE CUSTOMER, WHEN USING THE 960 MYCOBACTERIUM TUBERCULOSIS SIRE COMBINED DRUG SUSCEPTIBILITY KIT, FOUND THAT IN THE DRUG SUSCEPTIBILITY TUBES MADE OF THE SAME BOTTLE OF ETHAMBUTOL POWDER, THE RESULTS OF ETHAMBUTOL WERE ALL DRUG-RESISTANT, AND THE COLONY GROWTH FORM WAS ABNORMAL AND SHOWED EXCESSIVE GROWTH, AND THE COLONY FORM IN THE SAME BATCH OF 40 TUBES WAS HIGHLY CONSISTENT. IN ORDER TO ENSURE THE ACCURACY OF THE TEST, 40 RELEVANT SAMPLES WERE SUBSEQUENTLY RECHECKED (USING A NEW BOTTLE OF ETHAMBUTOL POWDER), AND THE RESULTS WERE ALL SENSITIVE AND NO COLONY GROWTH WAS SEEN, WHICH WAS SUSPECTED TO BE CAUSED BY THE FAILURE OF THE BOTTLE OF ETHAMBUTOL POWDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: THE CUSTOMER, WHEN USING THE 960 MYCOBACTERIUM TUBERCULOSIS SIRE COMBINED DRUG SUSCEPTIBILITY KIT, FOUND THAT IN THE DRUG SUSCEPTIBILITY TUBES MADE OF THE SAME BOTTLE OF ETHAMBUTOL POWDER, THE RESULTS OF ETHAMBUTOL WERE ALL DRUG-RESISTANT, AND THE COLONY GROWTH FORM WAS ABNORMAL AND SHOWED EXCESSIVE GROWTH, AND THE COLONY FORM IN THE SAME BATCH OF 40 TUBES WAS HIGHLY CONSISTENT. IN ORDER TO ENSURE THE ACCURACY OF THE TEST, 40 RELEVANT SAMPLES WERE SUBSEQUENTLY RECHECKED (USING A NEW BOTTLE OF ETHAMBUTOL POWDER), AND THE RESULTS WERE ALL SENSITIVE AND NO COLONY GROWTH WAS SEEN, WHICH WAS SUSPECTED TO BE CAUSED BY THE FAILURE OF THE BOTTLE OF ETHAMBUTOL POWDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, FALSE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: THE CUSTOMER, WHEN USING THE 960 MYCOBACTERIUM TUBERCULOSIS SIRE COMBINED DRUG SUSCEPTIBILITY KIT, FOUND THAT IN THE DRUG SUSCEPTIBILITY TUBES MADE OF THE SAME BOTTLE OF ETHAMBUTOL POWDER, THE RESULTS OF ETHAMBUTOL WERE ALL DRUG-RESISTANT, AND THE COLONY GROWTH FORM WAS ABNORMAL AND SHOWED EXCESSIVE GROWTH, AND THE COLONY FORM IN THE SAME BATCH OF 40 TUBES WAS HIGHLY CONSISTENT. IN ORDER TO ENSURE THE ACCURACY OF THE TEST, 40 RELEVANT SAMPLES WERE SUBSEQUENTLY RECHECKED (USING A NEW BOTTLE OF ETHAMBUTOL POWDER), AND THE RESULTS WERE ALL SENSITIVE AND NO COLONY GROWTH WAS SEEN, WHICH WAS SUSPECTED TO BE CAUSED BY THE FAILURE OF THE BOTTLE OF ETHAMBUTOL POWDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252007 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 245123 2111285 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown