BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 9286485 · Received November 6, 2019

    Report

    Report Number
    2243072-2019-02485
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 21, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD RECEIVED THE INSTRUMENT FROM THE CUSTOMER FACILITY FOR INVESTIGATION AND PERFORMED A TECHNICAL EVALUATION OF THE CUSTOMER'S SEDI-40 INSTRUMENT. THE EQUIPMENT WAS EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO ERROR WITH THE INCIDENT LOT WAS OBSERVED. IT WAS IDENTIFIED THAT THE INSTRUMENT HAD NEVER RECEIVED THE REQUIRED UPGRADE. AS A RESULT, THE UPGRADE TO THE INSTRUMENT WAS COMPLETED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE BD SEDI-40 HAS BEEN FOUND EXPERIENCING SAMPLE ID ERRORS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MIXER DOESN'T WORK, LLO ERROR.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE BD SEDI-40 HAS BEEN FOUND EXPERIENCING SAMPLE ID ERRORS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MIXER DOESN'T WORK, LLO ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077606 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON 00148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other