BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 9782769 · Received March 3, 2020

    Report

    Report Number
    2243072-2020-00317
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 7, 2020
    Report Date
    April 21, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/21/2020. H.6. INVESTIGATION: BD HAD PERFORMED A TECHNICAL EVALUATION OF THE CUSTOMER'S SEDI-40 INSTRUMENT. THE EQUIPMENT WAS EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STOPPED WORKING WITH THE INCIDENT LOT WAS OBSERVED. THE SERVICE REPORT IDENTIFIED THAT AS WELL AS BEING OUT OF CALIBRATION THE FAN WAS NOISY AND THE TUBE COVER WAS DAMAGED. IT WAS IDENTIFIED THAT THE INSTRUMENT WAS OUT OF CALIBRATION AND THE TUBE COVER WAS DAMAGED AND BOTH WERE REPLACED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SEDI-40 INSTRUMENT HAD A HARDWARE OR SOFTWARE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER INSERT THE TUBE INTO THE RACK OF THE INSTRUMENT. THE INSTRUMENT STARTS MIXING. AFTER THE MIXING PROCESS THE INSTRUMENT IS ANALYSING THE SAMPLE. AFTER A SHORT TIME PERIOD THE INSTRUMENT TERMINATES THE ANALYSIS DUE TO LLO ERROR MESSAGE. ALL REJECTED SAMPLES HAVE BEEN VERIFIED WITH INSTRUMENT SN (B)(6). WITH INSTRUMENT SN (B)(6), ALL SAMPLES CAN BE READ."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. OEM MANUFACTURE: 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SEDI-40 INSTRUMENT HAD A HARDWARE OR SOFTWARE MALFUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER INSERT THE TUBE INTO THE RACK OF THE INSTRUMENT. THE INSTRUMENT STARTS MIXING. AFTER THE MIXING PROCESS THE INSTRUMENT IS ANALYSING THE SAMPLE. AFTER A SHORT TIME PERIOD THE INSTRUMENT TERMINATES THE ANALYSIS DUE TO LLO ERROR MESSAGE. ALL REJECTED SAMPLES HAVE BEEN VERIFIED WITH INSTRUMENT SN (B)(4). WITH INSTRUMENT SN (B)(4), ALL SAMPLES CAN BE READ."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246852 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON 17-42042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other