BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
Report
- Report Number
- 1119779-2024-00281
- Event Type
- Injury
- Date Received
- April 10, 2024
- Date of Event
- February 19, 2024
- Report Date
- July 9, 2024
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- OOI
- UDI-DI
- 00382904419165
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G5. MULTIPLE 510(K): K111860, K130470. H3. 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: A FAILURE OF FALSE POSITIVE WAS REPORTED ON A MAX INSTRUMENT (P/N 441916, S/N (B)(6) ). THE CUSTOMER REPORTED THAT THEY RECEIVED FALSE POSITIVE RIF RESULTS FOR TWO DIFFERENT PATIENTS OF THE MDR-TB ASSAY. THE INSTRUMENT DATABASE WAS PROVIDED TO BD SERVICE AND R&D FOR FURTHER ANALYSIS. A BD FIELD SERVICE ENGINEER WAS DISPATCHED AND CHANGED READER A, RENORMALIZED AND RAN A TB TEST RUN. THERE WAS NO ISSUE OBSERVED ON READER B. THE INSTRUMENT WAS RETURNED TO THE CUSTOMER IN WORKING CONDITION. THIS IS A CONFIRMED FAILURE OF A BD PRODUCT. BD QUALITY DID NOT RECEIVE ANY RETURNED MATERIALS FOR REVIEW. REVIEW OF DEVICE HISTORY RECORD FOR (B)(6) IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND THE CONFIGURATION HAS CHANGED SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. SERVICE HISTORY FOR (B)(6) WAS REVIEWED AND REVEALED NO PREVIOUS COMPLAINTS RELATED TO FALSE POSITIVES. THE ROOT CAUSE IS UNKNOWN, BUT WAS RESOLVED AFTER RENORMALIZATION OF READER A. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS COMPLAINT.
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, THERE WAS A FALSE POSITIVE RESULT FOR RIF. THE PATIENT WAS TREATED WITH AN ADDITIONAL DRUG UNTIL CONFIRMATORY CULTURE RESULTS WERE RECEIVED. NO ADDITIONAL INFORMATION COULD BE PROVIDED REGARDING PATIENT IMPACT. ASSAYS USED: MDR-TB REPORT 1 OF 2 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO (2) SAMPLES OF SPUTA WAS COLLECTED FROM SAME PATIENT. FIRST SAMPLE BD MAX MTB POS, RIF NEG, INH UNREPORTABLE. CULTURE RIF SENSITIVE. SECOND SAMPLE BD MAX MTB POS, RIF POS, INH UNREPORTABLE. CULTURE RIF SENSITIVE. FIRST SAMPLE WAS INITIALLY REPORTED TO REMITTENT AS RIF NEGATIVE. WHEN SECOND SAMPLE WAS BD MAX RIF POSITIVE THE RESULT FOR FIRST SAMPLE WAS WITHDRAWN AND IT WAS COMMUNICATED TO REMITTENT THAT LABORATORY COULD NOT LEAVE SURE ANSWER SINCE RIF RESULTS WAS DISCREPANT AND THAT THERE COULD BE SEVERAL POSSIBILITIES EXPLAINING THIS INCLUDING HETERORESISTENS. JUST TO BE ON THE SURE SIDE TREATING DOCTOR DECIDED TO START TREATMENT WITH LEVOFLOXACIN AS AN ADDITION TO OTHER TREATMENT. WHEN CULTURE RESULTS (RIF SENSITIVE) WAS AVAILABLE TREATING DOCTOR WAS INFORMED ABOUT THE RESULTS AND LEVOFLOXACIN TREATMENT WAS STOPPED.
IT WAS REPORTED THAT DURING USE WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, THERE WAS A FALSE POSITIVE RESULT FOR RIF. THE PATIENT WAS TREATED WITH AN ADDITIONAL DRUG UNTIL CONFIRMATORY CULTURE RESULTS WERE RECEIVED. NO ADDITIONAL INFORMATION COULD BE PROVIDED REGARDING PATIENT IMPACT. ASSAYS USED: MDR-TB. REPORT 1 OF 2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429071 | BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT | INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS | OOI | BECTON, DICKINSON & CO. (SPARKS) | 00382904419165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |