PLATE BBL CHROMAGAR ORIENTATION
Report
- Report Number
- 9680577-2024-00035
- Event Type
- Malfunction
- Date Received
- November 14, 2024
- Date of Event
- October 15, 2024
- Report Date
- November 25, 2024
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JSH
- UDI-DI
- 30382902541074
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: THIS MEMO IS TO UPDATE THE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST BD BBL CHROMAGAR ORIENTATION AGAR, CATALOG NUMBER 254107, LOT NUMBER 4232591 WITH RESPECT TO A PERFORMANCE ISSUE. EVENT DESCRIPTION: THE CUSTOMER REPORTED LACTOBACILLI MISIDENTIFIED AS MYCOPLASMA ARGININI/ALKALESCENS DURING MALDI-TOF ANALYSIS. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY FOR THE PAST 12 MONTHS WAS REVIEWED, AND NO SIMILAR PERFORMANCE COMPLAINT THAT DESCRIBES MISIDENTIFYING OF LACTOBACILLI AS MYCOPLASMA ARGININI/ALKALESCENS WAS RECEIVED. A TREND WAS NOT IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO DEVIATIONS FROM THE VALIDATED PROCESS PARAMETERS WERE DETECTED. RELEASE TESTING BY THE QC DEPARTMENT WAS SATISFACTORY. INITIAL SAMPLE ANALYSIS: WITHIN THE COMPLAINT INVESTIGATION, RETAINMENT SAMPLES OF LOT 4232591 WERE ANALYZED ACCORDING TO THE QUALITY CONTROL RELEASE PARAMETERS. ALL TESTED STRAINS GREW ACCORDING TO THE SPECIFICATION. NEITHER RETURN NOR PICTURE SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR PRODUCTION PROCESS. NO DEVIATION COULD BE FOUND DURING THE QC RELEASE PERFORMANCE TEST AND THE PERFORMANCE TEST ON THE RETAIN SAMPLES. IN ADDITION, NO OTHER CUSTOMER HAS RAISED A SIMILAR COMPLAINT FOR THIS LOT NUMBER. WE CONSIDER THE OCCURRENCE A SINGLE EVENT. IF YOU ENCOUNTER PROBLEMS WITH MALDI RESULTS IN THE FUTURE, WE RECOMMEND USING ADDITIONAL METHODS FOR DETECTION. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION ON RETAIN SAMPLES, THE COMPLAINT CANNOT BE CONFIRMED. PLEASE NOTE THAT THE BRUKER USER MANUAL STATES THAT NO AGAR SHOULD BE TRANSFERRED WITH THE SAMPLE AND SPECIAL CARE NEEDS TO BE TAKEN WHEN HARVESTING COLONIES THAT GROW WITHIN THE AGAR. THUS, USING COLONIES WITH LARGER AMOUNTS OF AGAR OR JUST AGAR ALONE AS A TARGET CAN GIVE RESULTS THAT SHOULD BE INTERPRETED WITH CARE. THE MENTIONED PUBLICATION FROM LAGACÉ-WIENS DID NOT USE BD MEDIA AND OTHER PUBLICATIONS HAVE REPORTED SIMILAR RESULTS WITH OTHER MEDIA TYPES (BOKMA J, PARDON B, DEPREZ P, HAESEBROUCK F, BOYEN F. NON-SPECIFIC, AGAR MEDIUM-RELATED PEAKS CAN RESULT IN FALSE POSITIVE MYCOPLASMA ALKALESCENS AND MYCOPLASMA ARGININI IDENTIFICATION BY MALDI-TOF MS. RES VET SCI. 2020 JUN;130:139-143.) AT THIS STAGE, THIS COMPLAINT IS CONSIDERED A SINGLE INCIDENCE, WHICH COULD NOT BE REPRODUCED BY US AND NO FURTHER ACTIONS WILL BE TAKEN.
E1. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING PLATE BBL CHROMAGAR ORIENTATION THAT LACTOBACILLI WAS MISIDENTIFIED BY THE MALDI-TOF AS MYCOPLASMA ARGININI/ALKALESCENS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. PATIENT 2 OF 3.
IT WAS REPORTED WHILE USING PLATE BBL CHROMAGAR ORIENTATION THAT LACTOBACILLI WAS MISIDENTIFIED BY THE MALDI-TOF AS MYCOPLASMA ARGININI/ALKALESCENS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. PATIENT 2 OF 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1169727 | PLATE BBL CHROMAGAR ORIENTATION | CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL | JSH | BECTON DICKINSON GMBH | 4232591 | 30382902541074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |