BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40

    MDR report key: 9041626 · Received September 13, 2019

    Report

    Report Number
    2243072-2019-02021
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 22, 2019
    Report Date
    February 19, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    GHC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD PERFORMED A TECHNICAL EVALUATION OF THE CUSTOMER'S SEDI-40 INSTRUMENT. THE INSTRUMENT WAS TESTED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO ERROR WITH THE INCIDENT LOT WAS NOT OBSERVED . UPON COMPLETION OF THE INSTRUMENT EVALUATION, THE SERVICE TECHNICIAN DID FIND THAT THAT THE PLATE IN THE TUBE COVER WAS BROKEN, BUT STILL FUNCTIONAL AND IT HAD A NOISY FAN. BOTH PARTS WERE REPLACED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HARDWARE / SOFTWARE MALFUNCTION FOR ESR INSTRUMENT OCCURRED DURING USE WITH A BD SEDI-40. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT IS COMPLETELY OR PARTIALLY OUT OF ORDER AS THERE IS AN ERROR MESSAGE "LLO" IN SOME OR ALL POSITIONS. BUT IF THE RACKS ARE NOT COMPLETELY FULL WITH SAMPLES, IT SEEMS TO WORK. ERROR MESSAGE "LLO" IN SOME OR ALL POSITIONS."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HARDWARE / SOFTWARE MALFUNCTION FOR ESR INSTRUMENT OCCURRED DURING USE WITH A BD SEDI-40. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT IS COMPLETELY OR PARTIALLY OUT OF ORDER AS THERE IS AN ERROR MESSAGE "LLO" IN SOME OR ALL POSITIONS. BUT IF THE RACKS ARE NOT COMPLETELY FULL WITH SAMPLES, IT SEEMS TO WORK. ERROR MESSAGE "LLO" IN SOME OR ALL POSITIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838178 BD SEDI-40 ESR INSTRUMENT GHC BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other