BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT MP - 419744

    MDR report key: 9415985 · Received December 5, 2019

    Report

    Report Number
    3002769706-2019-00063
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Report Date
    October 14, 2020
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    PMA / PMN Number
    K190405
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN IRELAND NOTIFIED BIOMÉRIEUX OF OBTAINING TWENTY SEVEN (27) FALSE POSITIVE RESULTS FROM TWENTY-TWO (22) SEPARATE PATIENTS WHILE USING BACT/ALERT® MP BOTTLE (REF. (B)(4), LOT 1051733). THE FLAGGED POSITIVE BOTTLES WERE SUBCULTURED AND SMEARED (GRAM STAIN). THE SMEAR AND SUBCULTURE FOR ALL IMPACTED BOTTLES WERE NEGATIVE. IN RESPONSE TO THE CUSTOMER COMPLAINT, BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. EVALUATION OF THE DEVICE RECORDS ASSOCIATED WITH BACT/ALERT® MP BOTTLE LOT 1051733 IDENTIFIED THAT NO ANOMALIES WERE NOTED. ADDITIONALLY, LOT 1051733 MET FINAL AQL VISUAL INSPECTION ACCEPTANCE CRITERIA. PRODUCT RETAINS OF BACT/ALERT® MP BOTTLE LOT 1051733 WERE NOT REQUESTED FOR TESTING AS THE LOT WAS EXPIRED AT THE TIME OF THE COMPLAINT. THE ROOT CAUSE OF THE FALSE POSITIVE RESULTS OBTAINED BY THE CUSTOMER COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. NO BOTTLE GRAPHS, STORAGE DETAILS, ANSWERS TO QUESTIONS, SAMPLE SOURCES, PROCESSING METHOD/PROCEDURE, OR INSTRUMENT BACKUP WERE PROVIDED. THE INVESTIGATION CONFIRMED THE OCCURRENCE OF FALSE POSITIVE BOTTLES IS A KNOWN RISK; THE IMPACT TO THE PATIENT IS VERY LOW AS THE CONFIRMATORY SMEAR AND SUBCULTURE WILL SHOW IF ORGANISMS ARE PRESENT. THE INSTRUCTION TO SMEAR AND SUBCULTURE POSITIVE BOTTLES IS PRESENT IN THE BACT/ALERT® 3D USER MANUAL. SEE SECTION H10

    Additional Manufacturer Narrative · 0

    AFTER INITIAL SUBMISSION OF THIS REPORT, BIOMERIEUX OBTAINED THE FOLLOWING ADDITIONAL INFORMATION. THE NUMBER OF PATIENTS INVOLVED IN THIS EVENT WAS TWENTY-TWO (22). THERE IS STILL NO KNOWN ADVERSE IMPACT TO ANY PATIENT'S STATE OF HEALTH. THE AFFECTED BACT/ALERT® MP REFERENCE IS (B)(4), AND THE AFFECTED LOT NUMBER IS 1051733. THE DEVICE MANUFACTURE DATE IS 04-AUG-2019. THE 510K FOR PRODUCT REFERENCE 419744, IS K190405.

    Description of Event or Problem · 0

    AFTER INITIAL SUBMISSION OF THIS REPORT, BIOMERIEUX CONFIRMED THE NUMBER OF PATIENTS INVOLVED WITH THIS EVENT WAS TWENTY-TWO (22). THERE IS STILL NO KNOW IMPACT TO ANY PATIENT'S STATE OF HEALTH. THE AFFECTED BACT/ALERT® MP REFERENCE IS (B)(4), AND THE AFFECTED LOT NUMBER IS 1051733.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN IRELAND NOTIFIED BIOMÉRIEUX OF OBTAINING TWENTY SEVEN(27) FALSE POSITIVE RESULTS WHILE USING AN UNSPECIFIED LOT OF THE BACT/ALERT® MP BOTTLE (REF. 259797). BIOMÉRIEUX CUSTOMER SERVICE HAS REQUESTED THE AFFECTED LOT NUMBER(S), LAB REPORTS, AS WELL AS THE TECHNIQUE USED BY THE CUSTOMER FOR SAMPLE/BOTTLE HANDLING. AT THE TIME OF THIS ASSESSMENT THE CUSTOMER HAS NOT PROVIDED THIS INFORMATION. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE POSITIVE RESULTS LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209089 BACT/ALERT MP - 419744 BACT/ALERT MP - 419744 MDB BIOMERIEUX INC. 1051733

    Patients

    Seq Age Sex Outcome Treatment
    1