BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
Report
- Report Number
- 1119779-2021-01902
- Event Type
- Malfunction
- Date Received
- December 1, 2021
- Date of Event
- November 4, 2021
- Report Date
- March 22, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- OOI
- UDI-DI
- 00382904419165
- PMA / PMN Number
- K111860
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6) HAD A "FALSE POSITIVE" RESULT. CUSTOMER REPORTED THAT THEY ARE RECEIVING FREQUENT FALSE POSITIVE RESULTS. CUSTOMER REPORTED THAT THE FALSE POSITIVE ALSO OCCURRED IN THE NEGATIVE CONTROL. CUSTOMER CLEANED THE INSTRUMENT BUT THE ISSUE PERSIST. CUSTOMER CLEANED THE KEYBOARD, MOUSE, DOOR HANDLE AND REPERFORMED POSITIVE AND NEGATIVE CONTROL RUNS AFTER CLEANING. CUSTOMER REPORTED THAT THEY HAD 8 NEGATIVE CONTROL SAMPLES AND 1 YIELDED A FALSE POSITIVE. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE DISASSEMBLED AND CLEANED THE INSIDE OF THE INSTRUMENT. AFTER THREE CLEANING ATTEMPTS, THE ISSUE PERSISTED. FIELD SERVICE SECURE THE AIR CONDITIONER AND CLEANED THE INSTRUMENT AND RERAN THE SAMPLES. AFTER THREE RUNS, THERE WERE NO FALSE POSITIVE IN EMPTY SAMPLES. FIELD SERVICE OBSERVED THE CUSTOMER PERFORMED A RUN AND THE INSTRUMENT HAD A TIP PICK UP ERROR, BUT NO FALSE POSITIVE RESULTS. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR A FAILURE AT INSTALL. DEVICE WAS INSTALLED ON (B)(6) 2020, AND SINCE THEN OTHER SERVICE ACTIVITIES HAVE OCCURRED, SUCH AS PREVENTATIVE MAINTENANCE AND REPAIR, WHICH HAVE CHANGED THE CONFIGURATION OF THE INSTRUMENT SINCE RELEASE FROM MANUFACTURING. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDER WAS OBSERVED FOR THE FAILURE MODE REPORTED. NO SAMPLES WERE RETURNED FOR INVESTIGATION, THEREFORE RETURNED SAMPLE ANALYSIS IS NOT PERFORMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE COMPLAINT IS CONFIRMED BY FIELD SERVICE DURING DISPATCH. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR TRENDS ASSOCIATED WITH THIS FAILURE MODE.
IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS ARE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. ASSAY USED: UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CP VALUE HAS RISEN SHARPLY FROM AROUND 35 SINCE THE DAY BEFORE YESTERDAY, AND FALSE POSITIVES HAVE OCCURRED IN ABOUT HALF OF THE SAMPLES. WE ALSO CARRY OUT CLEANING, BUT I WOULD LIKE TO DISCUSS HOW TO DEAL WITH IT.
IT WAS REPORTED THAT WHILE TESTING WITH BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS ARE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. ASSAY USED: UNKNOWN THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CP VALUE HAS RISEN SHARPLY FROM AROUND 35 SINCE THE DAY BEFORE YESTERDAY, AND FALSE POSITIVES HAVE OCCURRED IN ABOUT HALF OF THE SAMPLES. WE ALSO CARRY OUT CLEANING, BUT I WOULD LIKE TO DISCUSS HOW TO DEAL WITH IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1808141 | BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT | INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS | OOI | BECTON, DICKINSON & CO. (SPARKS) | 441916 | NA | 00382904419165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |