BD BACTEC¿ MGIT¿ 960 SIRE KIT
Report
- Report Number
- 1119779-2022-01119
- Event Type
- Malfunction
- Date Received
- August 17, 2022
- Date of Event
- August 11, 2022
- Report Date
- October 26, 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: MGIT 960 SIRE SUPPLEMENT KIT BATCH 2011714 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 1309237, MGIT 960 STREPTOMYCIN BATCH 1321351, MGIT 960 ISONIAZID BATCH 1321352, MGIT 960 RIFAMPIN BATCH 132353 AND MGIT 960 ETHAMBUTOL BATCH 1321354. 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. HOWEVER, RETENTION SAMPLES WERE AVAILABLE FOR INSPECTION: STREPTOMYCIN BATCH 1321351 (10 VIALS), RIFAMPIN BATCH 1321353 (10 VIALS), ETHAMBUTOL BATCH 1321354 (10 VIALS) AND SIRE SUPPLEMENT BATCH 1309237 (6 VIALS). ALL RETENTION SAMPLES MAINTAINED ARE IN GOOD CONDITION. THE RETENTION SAMPLES WERE PERFORMANCE TESTED FOR GROWTH AND ANTIBIOTIC SUSCEPTIBILITY. ALL PERFORMANCE TESTED FOR ANTIBIOTIC GROWTH AND SUSCEPTIBILITY WAS SATISFACTORY AND IN ACCORDANCE WITH THE CERTIFICATE OF ANALYSIS. NO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE. THIS COMPLAINT CANNOT BE CONFIRMED. NOTES RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISK OF THE DEFECT REPORTED WAS ASSESSED AS SEVERITY [S1], PER [BALTRMLMBACTECMGITAPH, REV [2], ID [6.2]. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE TESTING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT THERE WAS FALSE SENSITIVITY. THERE ARE AT LEAST 10 REPORTED INCIDENTS OF FALSE SENSITIVITY WITH USE OF SIRE KIT. CONTROL STRAIN ATCC H37RV HAS ALSO FAILED AST TESTING 2 WEEKS IN A ROW. RESULTS WERE CONFIRMED TO BE INACCURATE VIA VISUAL GROWTH IN THE DRUG CONTAINING TUBES ALERTED CLINICAL STAFF TO POSSIBLE ISSUE. ISOLATES WERE RETESTED WITH THE SAME LOT AND PRODUCED "RESISTANT" RESULTS. LYSATE FROM THE ISOLATES WERE ALSO TESTED WITH A MOLECULAR PLATFORM THAT SHOWED GENE MUTATION THAT WOULD RENDER THE ISOLATES RESISTANT TO THE TESTED DRUGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS "FALSE SENSITIVITY WITH USE OF KIT BACTEC MGIT 960 SIRE LOT 2011714."
IT WAS REPORTED THAT WHILE TESTING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT THERE WAS FALSE SENSITIVITY. THERE ARE AT LEAST 10 REPORTED INCIDENTS OF FALSE SENSITIVITY WITH USE OF SIRE KIT. CONTROL STRAIN ATCC H37RV HAS ALSO FAILED AST TESTING 2 WEEKS IN A ROW. RESULTS WERE CONFIRMED TO BE INACCURATE VIA VISUAL GROWTH IN THE DRUG CONTAINING TUBES ALERTED CLINICAL STAFF TO POSSIBLE ISSUE. ISOLATES WERE RETESTED WITH THE SAME LOT AND PRODUCED "RESISTANT" RESULTS. LYSATE FROM THE ISOLATES WERE ALSO TESTED WITH A MOLECULAR PLATFORM THAT SHOWED GENE MUTATION THAT WOULD RENDER THE ISOLATES RESISTANT TO THE TESTED DRUGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS "FALSE SENSITIVITY WITH USE OF KIT BACTEC MGIT 960 SIRE LOT 2011714."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2245056 | BD BACTEC¿ MGIT¿ 960 SIRE KIT | SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL | MJA | BECTON, DICKINSON & CO. (SPARKS) | 245123 | 2011714 | 00382902451235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |