BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDI-40 INSTR.

    MDR report key: 8734614 · Received June 26, 2019

    Report

    Report Number
    2243072-2019-01265
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 6, 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
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: INSTRUMENT (B)(4) WAS RETURNED TO THE MANUFACTURER FOR SERVICE THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO & LHI FLAGGING WITH THE INCIDENT LOT WAS NOT OBSERVED. INVESTIGATION CONCLUSION: INSTRUMENT (B)(4) WAS RETURNED TO THE MANUFACTURER FOR SERVICE THE CUSTOMER'S INDICATED FAILURE MODE FOR LLO & LHI FLAGGING WITH THE INCIDENT LOT WAS NOT OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THE PRODUCT WAS FOUND TO BE IN CONFORMANCE AND MEET RELEASE SPECIFICATIONS. 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 SEDI-40 INSTR. EXPERIENCED ERRONEOUS RESULTS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LOT OF SAMPLES HAVE READING LLO AND HLO. EVEN ON SAME SAMPLES, ONE READING IS LOW, THEN ON SAME SAMPLE IS HIGH. (AFTER 5 MINUTES). CUSTOMER HAVE EXPERIENCE AND THEY CHECK BLOD LEVEL AND LABEL ON TUBE.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEDI-40 INSTR. EXPERIENCED ERRONEOUS RESULTS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A LOT OF SAMPLES HAVE READING LLO AND HLO. EVEN ON SAME SAMPLES, ONE READING IS LOW, THEN ON SAME SAMPLE IS HIGH. (AFTER 5 MINUTES). CUSTOMER HAS EXPERIENCE AND THEY CHECK BLOOD LEVEL AND LABEL ON TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530982 SEDI-40 INSTR. ESR INSTRUMENT JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other