BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
Report
- Report Number
- 3007420875-2022-00021
- Event Type
- Malfunction
- Date Received
- May 9, 2022
- Date of Event
- April 26, 2022
- Report Date
- October 3, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- OOI
- UDI-DI
- 00382904419165
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: MDR OWNERSHIP: UPDATED SITE LEGAL NAME: BECTON, DICKINSON & CO. - SPARKS, MD / 21152. B.5. UPDATED DEVICE NAME INVOLVED: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT. D.1. UPDATED MEDICAL DEVICE BRAND NAME: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT. D.2. UPDATED THE FOLLOWING: COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS , MEDICAL DEVICE TYPE: OOI. D.3. UPDATED MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (SPARKS). D.4. UPDATED THE FOLLOWING: MEDICAL DEVICE CATALOG #: 441916, MEDICAL DEVICE EXPIRATION. DATE: NA, UNIQUE IDENTIFIER #: (B)(4), MEDICAL DEVICE SERIAL #: (B)(6). G.1. UPDATED MANUFACTURING LOCATION: SPARKS, MD. G.4. INPUT DATE ADDITIONAL INFORMATION WAS RECEIVED: 06/08/2022. G.5. MULTIPLE 510K NUMBERS WERE REPORTED TO BE INVOLVED: K111860, K130470. H.4. UPDATED DEVICE MANUFACTURING DATE: 04/24/2018.
H.6 INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6) HAD A "FALSE POSITIVE" FOR TWO EVP ASSAY ANALYTES ON THE VIC AND ROX OPTICS. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT CT1288 IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. DEVICE WAS INSTALLED ON 02AUG2018. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT CT1288 AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. SAMPLE ANALYSIS CONSISTED OF REVIEW OF CUSTOMER RUN FILES BY QUALITY. QUALITY FOUND EVIDENCE OF READER NORMALIZER SIGNAL DRIFT AFFECTING BOTH THE ROX (585) AND VIC (530) SIGNALS. NORMALIZER DRIFT IS EXACERBATED WHEN DEALING WITH INTERLEAVED RUNS. AN INTERNAL CAPA IS OPEN TO ADDRESS THIS ISSUE. THE COMPLAINT IS CONFIRMED BY QUALITY. THE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. COMPLAINT HISTORY FOR ¿RESULTS¿ WAS REVIEWED FOR THE MONTH OF APRIL 2022. THE UPPER CONTROL LIMIT WAS NOT BREACHED, AND TRENDS WERE NOT IDENTIFIED ASSOCIATED WITH THIS DEFECT. REVIEW OF RISK MANAGEMENT DOCUMENTATION INDICATES THAT THE POTENTIAL RISK OF THE REPORTED FAILURE MODE WAS ASSESSED AS SEVERITY S3 WITH POTENTIAL HARM IS INCORRECT THERAPY, POSSIBLE MEDICATION ADVERSE EVENT VIA DOCUMENT BALTRM-MAXINST-APH, REVISION 21, LINE HW 70. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. SPECIMENS WERE TESTED AGAIN AND CAME BACK NEGATIVE. THE NEGATIVE RESULTS WERE DEEMED TO BE ACCEPTABLE. THIS EVENT OCCURRED 3 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER, THE 3 SPECIMENS HAD DISCREPANT RESULTS FOR MULTIPLE TARGETS. CUSTOMER STATES THEY REPEATED THE SPECIMENS AND THEN THE RESULTS WERE ACCEPTABLE AS NEGATIVE. PER CUSTOMER, THIS IS AN ONGOING ISSUE WITH THIS ASSAY. CUSTOMER ALREADY PERFORMED EM WITH 5 SWABS AND 7 BLANKS/NEGATIVES AND ALL RESULTS WERE ACCEPTABLE."
IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. SPECIMENS WERE TESTED AGAIN AND CAME BACK NEGATIVE. THE NEGATIVE RESULTS WERE DEEMED TO BE ACCEPTABLE. THIS EVENT OCCURRED 3 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER, THE 3 SPECIMENS HAD DISCREPANT RESULTS FOR MULTIPLE TARGETS. CUSTOMER STATES THEY REPEATED THE SPECIMENS AND THEN THE RESULTS WERE ACCEPTABLE AS NEGATIVE. PER CUSTOMER, THIS IS AN ONGOING ISSUE WITH THIS ASSAY. CUSTOMER ALREADY PERFORMED EM WITH 5 SWABS AND 7 BLANKS/NEGATIVES AND ALL RESULTS WERE ACCEPTABLE."
IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THE CUSTOMER RECEIVED FALSE POSITIVE RESULTS. SPECIMENS WERE TESTED AGAIN AND CAME BACK NEGATIVE. THE NEGATIVE RESULTS WERE DEEMED TO BE ACCEPTABLE. THIS EVENT OCCURRED 3 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER, THE 3 SPECIMENS HAD DISCREPANT RESULTS FOR MULTIPLE TARGETS. CUSTOMER STATES THEY REPEATED THE SPECIMENS AND THEN THE RESULTS WERE ACCEPTABLE AS NEGATIVE. PER CUSTOMER, THIS IS AN ONGOING ISSUE WITH THIS ASSAY. CUSTOMER ALREADY PERFORMED EM WITH 5 SWABS AND 7 BLANKS/NEGATIVES AND ALL RESULTS WERE ACCEPTABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1071229 | BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT | INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS | OOI | BECTON, DICKINSON & CO. (SPARKS) | 443985 | 2011738 | 00382904419165 |
| 2065122 | BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT | INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS | OOI | BECTON, DICKINSON & CO. (SPARKS) | 443985 | 2011738 | 00382904419165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |