BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

Report

Report Number: 1119779-2021-01853
Event Type: Malfunction
Date Received: November 18, 2021
Date of Event: November 1, 2021
Report Date: March 24, 2022
Manufacturer: BECTON, DICKINSON & CO. (SPARKS)
Product Code: OOI
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1209769. MEDICAL DEVICE EXPIRATION DATE: 03/18/2022. DEVICE MANUFACTURE DATE: 07/28/2021. MEDICAL DEVICE LOT #: 1228396. MEDICAL DEVICE EXPIRATION DATE: 03/11/2022. DEVICE MANUFACTURE DATE: 08/16/2021. MEDICAL DEVICE LOT #: 1251621. MEDICAL DEVICE EXPIRATION DATE: 03/11/2022. DEVICE MANUFACTURE DATE: 09/08/2021. EUA # (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative · 0

AN ADDITIONAL LOT HAS BEEN ADDED TO THIS COMPLAINT: D4. MEDICAL DEVICE LOT #: 1243693. D4. MEDICAL DEVICE EXPIRATION DATE: 2022-03-25. H4. DEVICE MANUFACTURE DATE: 2021-08-31.

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS WERE CORRECTED: B5. IT WAS REPORTED WHILE TESTING WITH BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT A FALSE POSITIVE RESULT WAS OBTAINED. THIS OCCURRED 17 TIMES. CONFIRMATORY TESTING WAS PERFORMED AND THE RESULTS WERE NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: SARS COV-2 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT CUSTOMER REPORTS MULTIPLE DISCREPANT RESULTS WHILE USING MULTIPLE LOTS OF CAT 44500301. PER CUSTOMER, "THE DISCREPANT RESULTS ARE OVERWHELMINGLY ON THE A SIDE OF THE INSTRUMENT, BUT THEY DO NOT FOLLOW A PATTERN THAT I CAN SEE." WHEN THEY REPEAT THE SPECIMENS ON A DIFFERENT PLATFORM, ALL RESULTS ARE NEGATIVE. D1. MEDICAL DEVICE BRAND NAME: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT D2A. COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS D2B. MEDICAL DEVICE TYPE: OOI D4: CATALOG #: 441916 SERIAL #: (B)(6) UDI #: (B)(4) G5. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED: K111860, K130470 H4. DEVICE MANUFACTURE DATE: 2020-05-04 H5. LABELED FOR SINGLE USE?: NO.

Additional Manufacturer Narrative · 0

THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1209769. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2022. DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1228396. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2022. DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1251621. MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2022. DEVICE MANUFACTURE DATE: (B)(6) 2021. EUA # (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative · 0

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 N1 POSITIVE RESULTS. CUSTOMER REPORTED THAT THEY HAVE REPEATED THE SAMPLES ON ANOTHER PLATFORM AND THE RESULTS WERE NEGATIVE. CUSTOMER HAS BEEN CLEANING EXTENSIVELY AND PERFORMING 12 ENVIRONMENTAL MONITORING, WITH ACCEPTABLE RESULTS. BUT THE ISSUE STILL PERSIST AFTER EM. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE VERIFIED CALIBRATION AND INSTRUMENT SETTINGS. FIELD SERVICE REPLACED PUMP #1 AND #2 AND ALL THE PUMP TUBING. FIELD SERVICE COMPLETED HEALTH CHECK AND PERFORMED A SUCCESSFUL QUALIFICATION. 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 23JUN2020, 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)(4) AND IN OCTOBER 2021, THE INSTRUMENT EXPERIENCED N1 POSITIVE ON A VALIDATION SAMPLE. CUSTOMER PERFORMED ENVIRONMENTAL MONITORING AND DEEP CLEANING OF THE INSTRUMENT. FIELD SERVICE ASSISTED IN DECONTAMINATION EFFORT. QUALITY DID NOT RECEIVE SAMPLES FOR THIS INVESTIGATION AND THUS, ROOT CAUSE COULD NOT BE DETERMINED AND SAMPLE ANALYSIS DID NOT OCCUR. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED AND INVESTIGATION WILL OCCUR. THE COMPLAINT IS CONFIRMED BY FIELD SERVICE DURING DISPATCH.