BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 14148768 · Received April 19, 2022

    Report

    Report Number
    1119779-2022-00578
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 21, 2022
    Report Date
    June 15, 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
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: PMA / 510(K)#: K111860, K130470. 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

    INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916AND SERIAL NUMBER (B)(6)) HAD A "FALSE POSITIVE¿. CUSTOMER REPORTED THAT THEY ARE STILL RECEIVING FALSE N1 AND N2 POSITIVE RESULTS EVEN AFTER DECONTAMINATION EFFORT. CUSTOMER PERFORMED EM AND RECEIVED POSITIVE RESULTS ON VORTEX, PREWARM, AND REAGENT KIT BOX. CUSTOMER DECONTAMINATED THOSE AREAS AND RECEIVED NEGATIVE EM RESULTS. ISSUE WAS RESOLVED. 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 COMPLAINT FAILURE MODE REPORTED. NO SAMPLES WERE RETURNED FOR INVESTIGATION, THEREFORE RETURNED SAMPLE ANALYSIS WAS NOT PERFORMED. ROOT CAUSE IS DETERMINED TO BE DUE TO CONTAMINATION ON THE VORTEX, PREWARM, AND REAGENT KIT BOX. COMPLAINT IS UNCONFIRMED AS THE ISSUE IS NOT INSTRUMENT RELATED AND IS RELATED TO WORKFLOW.

    Description of Event or Problem · 0

    REPORT 2 OF 3. IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED WITH FISHER MESA ACCULA RAPID-PCR AND THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: SARS-COV-2 (EUA200159). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONCERN: SARS COV2 DISCREPANT RESULTS. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: COLLECTED INFORMATION BELOW: INCIDENT DATE(S): (B)(6) 2022 AND (B)(6) 2022. INSTRUMENT SN AND SW VERSION: CT1981 SW V5.14A. REFERENCE AND LOT NUMBERS OF REAGENT'S KITS: LOT# 2018237. SAMPLES AFFECTED (PATIENT OR EXTERNAL CONTROL): PATIENT. SAMPLE COLLECTION MEDIA TYPE AND SIZE (1ML/3ML, ETC): 3ML. WHAT DO YOU USE FOR EXTERNAL CONTROLS AND HOW DO YOU PREPARE THEM? CUSTOMER USES ZEPTOMETRIX.. WHAT ARE THE RUN NUMBERS AND SAMPLE POSITIONS FOR EACH AFFECTED SAMPLE? RUN#1747- A3 POSITIVE FOR N1,N2; REPEATED NEGATIVE FISHER'S MESA ACCULA RAPID-PCR WHAT ARE THE RESULTS OF YOUR MOST RECENT ENVIRONMENTAL MONITORING RUN? LAST MONTH - NEGATIVE. FINAL RESULTS REPORTED TO CLINICIAN: NEGATIVE. ADVERSE EFFECT ON PATIENT, IF ANY: NA. TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: NA. HAS MAX ASSAY UDP/IDF BEEN VERIFIED AGAINST MOST RECENT PACKAGE INSERT? YES. IS YOUR BD MAX CONNECTED REMOTELY TO BD VIA ASSURITY-LINC OR RSS? NO. DB AND RUN FILES COLLECTED VIA BOMGAR. Q:\BD MAX ACCOUNTS\(B)(6).

    Description of Event or Problem · 0

    REPORT 2 OF 3 IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED WITH FISHER MESA ACCULA RAPID-PCR AND THE RESULT WAS NEGATIVE. ERRONEOUS RESULTS WERE NOT REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: SARS-COV-2 (EUA(B)(4)) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CONCERN: SARS COV2 DISCREPANT RESULTS STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: COLLECTED INFORMATION BELOW: INCIDENT DATE(S): (B)(6)2022 AND (B)(6)2022 INSTRUMENT SN AND SW VERSION: (B)(6) SW V5.14A REFERENCE AND LOT NUMBERS OF REAGENT'S KITS: LOT# 2018237 SAMPLES AFFECTED (PATIENT OR EXTERNAL CONTROL): PATIENT SAMPLE COLLECTION MEDIA TYPE AND SIZE (1ML/3ML, ETC): 3ML WHAT DO YOU USE FOR EXTERNAL CONTROLS AND HOW DO YOU PREPARE THEM? CUSTOMER USES ZEPTOMETRIX. WHAT ARE THE RUN NUMBERS AND SAMPLE POSITIONS FOR EACH AFFECTED SAMPLE? RUN#1747- A3 POSITIVE FOR N1,N2; REPEATED NEGATIVE FISHER'S MESA ACCULA RAPID-PCR WHAT ARE THE RESULTS OF YOUR MOST RECENT ENVIRONMENTAL MONITORING RUN? LAST MONTH - NEGATIVE FINAL RESULTS REPORTED TO CLINICIAN: NEGATIVE ADVERSE EFFECT ON PATIENT, IF ANY: NA TREATMENT OR MEDICATIONS RECEIVED BY THE PATIENT, IF ANY: NA HAS MAX ASSAY UDP/IDF BEEN VERIFIED AGAINST MOST RECENT PACKAGE INSERT? YES IS YOUR BD MAX CONNECTED REMOTELY TO BD VIA ASSURITY-LINC OR RSS? NO DB AND RUN FILES COLLECTED VIA BOMGAR Q:\BD MAX ACCOUNTS\CRITTENDEN(B)(6)HOSPITAL\01637354

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367509 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 441916 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown