BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 8901936 · Received August 16, 2019

    Report

    Report Number
    2243072-2019-01742
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 2, 2019
    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: BD RECEIVED SERVICE REPORT FOR THE INVESTIGATION. THE EQUIPMENT WAS TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO ERROR WITH THE INCIDENT LOT WAS NOT OBSERVED AS WAS FOUND TO BE FUNCTIONING CORRECTLY. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 ERRONEOUS RESULTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LLO ERROR, (THE BLOOD COLLECTION TUBES WERE FILLED CORRECTLY) ALSO, SEVERAL TIMES QC VALUES BELOW THE RANGE.

    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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 ERRONEOUS RESULTS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LLO ERROR, (THE BLOOD COLLECTION TUBES WERE FILLED CORRECTLY) ALSO, SEVERAL TIMES QC VALUES BELOW THE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696868 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other