BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 8662879 · Received June 3, 2019

    Report

    Report Number
    2243072-2019-01071
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 17, 2019
    Report Date
    July 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: INSTRUMENT SEDI 40 00211 WAS RETURNED TO THE MANUFACTURER FOR SERVICE THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO & LHI FLAGGING WITH THE INCIDENT LOT WAS OBSERVED. INVESTIGATION CONCLUSION: INSTRUMENT SEDI 40 00211 WAS RETURNED TO THE MANUFACTURER FOR SERVICE THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO & LHI FLAGGING WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: THE SERVICE REPORT IDENTIFIED THAT, ON RECEIPT, THE INSTRUMENT WAS TESTED AND A DAMAGED PLATE WAS FOUND IN THE SAMPLE HOLDER, THERE WAS ALSO EVIDENCE OF LLO AND FLAGGING, HOWEVER THE LEVEL OF ERROR INDICATED THAT THE SETTINGS ON THE INSTRUMENT HAD BEEN SIGNIFICANTLY ADJUSTED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SEDI-40 DISPLAYED A "TOO LOW BLOOD LEVEL" ERROR DESPITE PROPER TUBES WITH THE PROPER AMOUNT OF BLOOD BEING INSERTED INTO IT, RESULTING IN NO MEASUREMENTS BEING PROCESSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SEDI-40 MACHINE DISPLAYS ¿TOO LOW BLOOD LEVEL¿ WHEN PROPER SEDIMENTATION TUBES HAVE BEEN INSERTED WITH PROPER AMOUNT OF BLOOD. THIS HAPPENS REGULARLY IN APPROX. HALF (9-10 PCS) OF THE 20 COMPARTMENTS. IN THIS CASE THERE IS NO MEASUREMENT PROCESSED. THE SECONDARY SEDI-40 MACHINE OF THE LABORATORY WORKS AND CAN MEASURE THESE TUBES ALSO."

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SEDI-40 DISPLAYED A "TOO LOW BLOOD LEVEL" ERROR DESPITE PROPER TUBES WITH THE PROPER AMOUNT OF BLOOD BEING INSERTED INTO IT, RESULTING IN NO MEASUREMENTS BEING PROCESSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SEDI-40 MACHINE DISPLAYS ¿TOO LOW BLOOD LEVEL¿ WHEN PROPER SEDIMENTATION TUBES HAVE BEEN INSERTED WITH PROPER AMOUNT OF BLOOD. THIS HAPPENS REGULARLY IN APPROX. HALF (9-10 PCS) OF THE 20 COMPARTMENTS. IN THIS CASE THERE IS NO MEASUREMENT PROCESSED. THE SECONDARY SEDI-40 MACHINE OF THE LABORATORY WORKS AND CAN MEASURE THESE TUBES ALSO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457706 BD SEDI-40 ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other