BD BACTEC¿ MGIT¿ 960 PZA KIT
Report
- Report Number
- 1119779-2023-00474
- Event Type
- Malfunction
- Date Received
- April 25, 2023
- Date of Event
- February 17, 2023
- Report Date
- September 6, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- MJA
- UDI-DI
- 00382902451280
- PMA / PMN Number
- K021582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D9: DEVICE AVAILABLE FOR EVALUATION: YES. D.9:DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 2023-APRIL-06. H.6 INVESTIGATION SUMMARY: BACTEC MGIT 960 PZA 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. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). BACTEC MGIT 960 PZA 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. TWO BACTEC MGIT 960 PZA VIALS ARE THEN MANUALLY PACKAGED WITH SIX BACTEC MGIT 960 PZA SUPPLEMENT VIALS TO COMPLETE A BACTEC MGIT 960 PZA KIT (MATERIAL 245128). KIT BATCHES 2160598 AND 2160583. MGIT 960 PZA KIT BATCHES 2160598 AND 2160583 ARE COMPOSED OF MGIT PZA BATCH 2110643 AND MGIT 960 PZA SUPPLEMENT BATCH 2095099. THE BATCH HISTORY RECORD REVIEWS FOR MGIT 960 PZA KIT BATCHES 2160598 AND 2160583 WERE SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING OTHER COMPLAINTS HAVE BEEN TAKEN ON THESE KIT BATCHES FOR PERFORMANCE ISSUES ALL WHICH ALSO WERE NOT CONFIRMED. THE BATCH HISTORY RECORD REVIEWS FOR MGIT PZA BATCH 2110643 AND MGIT PZA SUPPLEMENT BATCH 2095099 WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE FORMULATION PROCESSES WERE EACH WITHIN SPECIFICATION, AND QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTION SAMPLES FROM PZA SUPPLEMENT BATCH 2095099 (8 VIALS) AND PZA BATCH 2110643 (8 VIALS) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES WERE PERFORMANCE TESTED FOR SUSCEPTIBILITY PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE PRODUCT INSERT AND INCLUDES MYCOBACTERIUM TUBERCULOSIS SUBSP. TUBERCULOSIS (B)(6). ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURES, INCLUDING SENSITIVITY FOR (B)(6) AS EXPECTED. RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. A PZA KIT CARTON FROM BATCH 2160598 WAS RECEIVED IN AN INSULATED SHIPPING BOX. FIVE UNOPENED SUPPLEMENT VIALS FROM BATCH 2095099 AND TWO UNOPENED PZA DRUG VIALS FROM BATCH 2110643 WERE RETURNED. THE RETURNED SAMPLES WERE PERFORMANCE TESTED FOR SUSCEPTIBILITY PER THE STANDARD PERFORMANCE PROCEDURE. ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURES, INCLUDING SENSITIVITY FOR (B)(6) AS EXPECTED. NO RETURN SAMPLES WERE RECEIVED FROM KIT BATCH 2160583 BUT IT IS NOTED THAT THE COMPONENTS PACKAGED IN KIT BATCH 2160583 ARE THE SAME COMPONENTS IN KIT BATCH 2160598. KIT BATCH 2174034. MGIT 960 PZA KIT BATCH 2174034 IS COMPOSED OF MGIT PZA BATCH 2053011 AND MGIT 960 PZA SUPPLEMENT BATCH 2137387. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 PZA KIT BATCH 2174034 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR PERFORMANCE. THE BATCH HISTORY RECORD REVIEWS FOR MGIT PZA BATCH 2053011 AND MGIT PZA SUPPLEMENT BATCH 2137387 WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND INSPECTION. THE FORMULATION PROCESSES WERE EACH WITHIN SPECIFICATION, AND QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTION SAMPLES FROM PZA SUPPLEMENT BATCH 2137387 (14 VIALS) AND PZA BATCH 2053011 (8 VIALS) WERE AVAILABLE FOR INSPECTION. THE RETENTION SAMPLES WERE PERFORMANCE TESTED FOR SUSCEPTIBILITY PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE PRODUCT INSERT AND INCLUDES MYCOBACTERIUM TUBERCULOSIS SUBSP. TUBERCULOSIS (B)(6). ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURES, INCLUDING SENSITIVITY FOR (B)(6) AS EXPECTED. NO RETURNS SAMPLES WERE RECEIVED FROM KIT BATCH 2174034. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. ALL RETURN SAMPLE AND RETENTION SAMPLE TESTING FOR THE BATCHES IN QUESTION WERE SATISFACTORY PER BD PROCEDURES. NO PERFORMANCE DEFECT WAS FOUND. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE DEFECTS.
D.3 COMMON DEVICE NAME: SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
PATIENT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT THAT THERE WAS FALSE RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONLY 2 ERRONEOUS RESULTS ALLEGED. PT # 2 SET UP DATE (B)(6), REMOVAL DATE (B)(6), LOT # 2174034. PATIENT #2 RESULT WAS NOT REPORTED. PT # 4 WAS RESULTED OUT AS RESISTANT, SET UP ON (B)(6), REMOVAL DATE (B)(6), LOT # 2160598. FOR PATIENT RESULTS - HOW MANY FALSE RESULTS WERE REPORTED OUT (S OR R): PATIENT # 4 WAS RESULTED OUT AS RESISTANT, SET UP ON (B)(6) LOT # 2160598 NO OTHER PATIENT RESULTS REPORTED ALL PATIENTS SENT OUT FOR CONFIRMATORY TESTING. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): RESISTANCE AND SUSCEPTIBILITY OF REPEATED QC AND PATIENTS. 1. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? RESISTANT OR SUSCEPTIBLE. 2. WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) RESISTANT OR SUSCEPTIBLE. 3. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? QC AND PATIENT. 4. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? UNKNOWN. 5. DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? UNKNOWN. CUSTOMER STATES ERRONEOUS RESULTS WITH MULTIPLE LOTS.
PATIENT 1 OF 2. IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT THAT THERE WAS FALSE RESISTANCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONLY 2 ERRONEOUS RESULTS ALLEGED. PT # 2 SET UP DATE 2/10, REMOVAL DATE 2/17, LOT # 2174034. PATIENT #2 RESULT WAS NOT REPORTED PT # 4 WAS RESULTED OUT AS RESISTANT, SET UP ON 3/21, REMOVAL DATE 3/27, LOT # 2160598. FOR PATIENT RESULTS - HOW MANY FALSE RESULTS WERE REPORTED OUT (S OR R): PATIENT # 4 WAS RESULTED OUT AS RESISTANT, SET UP ON 3/21 LOT # 2160598. NO OTHER PATIENT RESULTS REPORTED . ALL PATIENTS SENT OUT FOR CONFIRMATORY TESTING . HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID ERRONEOUS RESULTS OCCUR? YES. IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): RESISTANCE AND SUSCEPTIBILITY OF REPEATED QC AND PATIENTS. WHAT RESULT DID THE CUSTOMER OBTAIN FROM THE BD PRODUCT? RESISTANT OR SUSCEPTIBLE . WHAT RESULT WAS THE CUSTOMER EXPECTING TO OBTAIN (IF DIFFERENT FROM THE OBTAINED RESULT) RESISTANT OR SUSCEPTIBLE. WAS THIS A QC, VALIDATION, OR PROFICIENCY TEST? QC AND PATIENT. WAS PATIENT TREATMENT CHANGED AS A CONSEQUENCE OF THE ISSUE WITH RESULTS? UNKNOWN . DID THE PATIENT SUFFER ANY ADVERSE MEDICAL CONSEQUENCES AS A RESULT OF THE CHANGE IN TREATMENT? UNKNOWN. CUSTOMER STATES ERRONEOUS RESULTS WITH MULTIPLE LOTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1210420 | BD BACTEC¿ MGIT¿ 960 PZA KIT | SEE H.10 | MJA | BECTON, DICKINSON & CO. (SPARKS) | 245128 | 2174034 | 00382902451280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |