BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 8884766 · Received August 12, 2019

    Report

    Report Number
    2243072-2019-01676
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 26, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. THE INSTRUMENT WAS TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR INSTRUMENT REJECTS SAMPLES AS LLO WITH THE INCIDENT LOT WAS NOT OBSERVED AS THE INSTRUMENT WAS FUNCTIONING CORRECTLY, ALTHOUGH IT WAS EXPLAINED THAT IF TUBES ARE SIGNIFICANTLY OVERFILLED AN ERROR RESPONSE CAN BE GENERATED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD SEDI-40 HAS BEEN FOUND EXPERIENCING HARDWARE/SOFTWARE MALFUNCTION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT REJECTS THE SAMPLES AS LLO DESPITE THE TUBES ARE FILLED CORRECTLY. IT ALSO DID NOT READ QC RESULTS. QC RESULT (ZEROS) LLO ERROR MESSAGE TUBE FILL THE ERROR REPEATED TWICE ON DIFFERENT TUBES, SOCKETS 1 AND 2.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS ELITECH. 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 THE BD SEDI-40 HAS BEEN FOUND EXPERIENCING HARDWARE/SOFTWARE MALFUNCTION DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE INSTRUMENT REJECTS THE SAMPLES AS LLO DESPITE THE TUBES ARE FILLED CORRECTLY. IT ALSO DID NOT READ QC RESULTS. QC RESULT (ZEROS). LLO ERROR MESSAGE. TUBE FILL. THE ERROR REPEATED TWICE ON DIFFERENT TUBES, SOCKETS 1 AND 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679323 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other