BD BACTEC¿ MGIT¿ 960 PZA KIT
Report
- Report Number
- 1119779-2024-00681
- Event Type
- Malfunction
- Date Received
- September 20, 2024
- Date of Event
- December 8, 2023
- Report Date
- March 10, 2025
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- MJA
- UDI-DI
- 00382902451280
- PMA / PMN Number
- K021582
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
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). THE BATCH HISTORY RECORD FOR BATCH: 33233971 AND ITS COMPONENTS WAS SATISFACTORY. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING) OR RESERVED FOR FURTHER INVESTIGATIONAL TESTING INTO THIS ISSUE. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT IS CONFIRMED. TREND IN PERFORMANCE COMPLAINTS IDENTIFIED FOR (B)(4) MGIT PZA KIT. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE THE PERFORMANCE ISSUE. FOR IMPACTED BATCHES THAT WERE RELEASED, A FIELD ACTION HAS BEEN EXECUTED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: FROM UNKNOWN TO 3233971. D4. MEDICAL DEVICE EXPIRATION DATE: FROM UNKNOWN TO 22-NOV-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: FROM UNKNOWN TO 21-AUG-2023.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, A FALSE PZA RESISTANT RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. CONFIRMATORY PNCA GENE SEQUENCING WAS PERFORMED AND NO MUTATIONS WERE DETECTED INDICATING THE PZA RESULT WAS SUSCEPTIBLE. THE PATIENT'S TREATMENT WAS CHANGED BASED ON THE ERRONEOUS PZA RESULT FROM PZA TO MOXIFLOXACIN ANTIBIOTIC. THERE WERE NO FURTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, A FALSE PZA RESISTANT RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. CONFIRMATORY PNCA GENE SEQUENCING WAS PERFORMED AND NO MUTATIONS WERE DETECTED INDICATING THE PZA RESULT WAS SUSCEPTIBLE. THE PATIENT'S TREATMENT WAS CHANGED BASED ON THE ERRONEOUS PZA RESULT FROM PZA TO MOXIFLOXACIN ANTIBIOTIC. THERE WERE NO FURTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, A FALSE PZA RESISTANT RESULT WAS OBTAINED FOR ONE (1) PATIENT SAMPLE. CONFIRMATORY PNCA GENE SEQUENCING WAS PERFORMED AND NO MUTATIONS WERE DETECTED INDICATING THE PZA RESULT WAS SUSCEPTIBLE. THE PATIENT'S TREATMENT WAS CHANGED BASED ON THE ERRONEOUS PZA RESULT FROM PZA TO MOXIFLOXACIN ANTIBIOTIC. THERE WERE NO FURTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1354084 | BD BACTEC¿ MGIT¿ 960 PZA KIT | SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL | MJA | BECTON DICKINSON & CO. (SPARKS) | 3233971 | 00382902451280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |