BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
Report
- Report Number
- 3007420875-2021-00051
- Event Type
- Malfunction
- Date Received
- September 10, 2021
- Date of Event
- August 13, 2021
- Report Date
- February 21, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- OOI
- PMA / PMN Number
- K181427
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE KIT BD MAX ENTERIC VIRAL PANEL CATALOG NUMBER 4403985 WHICH HAS 510K NUMBER K181427.
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 RECEIVING FALSE POSITIVE RESULTS ON NORO FOR EVP ASSAY. REVIEW OF THE DATABASE SHOWS THAT IN THE RAW DATA CURVE, THERE WERE WEAK BUT TRUE AMPLIFICATION. CURVES WERE SHAKY BUT STILL TRENDING UPWARD. FOLLOW-UP ON WITH THE CUSTOMER CONCLUDED THAT THE CUSTOMER BELIEVED THAT THE INCIDENT WAS WORKFLOW RELATED. CUSTOMER BELIEVED THAT THEY HAD OVER-INOCULATE THE SAMPLE. NO ACTION WAS TAKEN FOR THIS COMPLAINT. 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 EXPECTED TO BE RETURNED FOR INVESTIGATION, THEREFORE RETURN SAMPLE ANALYSIS IS NOT REQUIRED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. COMPLAINT IS UNCONFIRMED BASED ON REVIEW OF LOG FILE AND CUSTOMER FEEDBACK. 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.
THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTIONS: B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORO POSITIVE, NEGATIVE ON CEPHEID". D.1. DEVICE BRAND NAME: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT. D.2. COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS; PRODUCT CODE: OOI. D.3. MANUFACTURING SITE: BECTON, DICKINSON & CO. (SPARKS). D.4. CATALOG NUMBER: 441916; SERIAL NUMBER: (B)(6); UDI NUMBER: (B)(4). G.1. MANUFACTURING SITE: BECTON, DICKINSON & CO. (SPARKS). G.4. PMA/510K#: K111860, K130470.
IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL-NR EU FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORO POSITIVE, NEGATIVE ON CEPHEID"
IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORO POSITIVE, NEGATIVE ON CEPHEID".
IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A CEPHEID TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NORO POSITIVE, NEGATIVE ON CEPHEID".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1352468 | BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT | INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS | OOI | BECTON, DICKINSON & CO. (SPARKS) | 1039578 | ||
| 1352469 | BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT | INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS | OOI | BECTON, DICKINSON & CO. (SPARKS) | 1039578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |