BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SEDI-40 INSTR. DEFECTIVE

    MDR report key: 13447468 · Received February 3, 2022

    Report

    Report Number
    2243072-2022-00148
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 21, 2022
    Report Date
    March 8, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    K953994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2022-01-21. INVESTIGATION SUMMARY INSTRUMENT SEDI 40 00142 WAS RETURNED TO THE MANUFACTURER FOR SERVICE WITH RESPECT TO THE REPORTED DEFECT ¿ NOT RECOGNIZING SAMPLES. THE INSTRUMENT WAS CLEANED AND EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND NO ISSUES WERE DETECTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SEDI-40 INSTR. DEFECTIVE, THE DEVICE EXPERIENCED HARDWARE / SOFTWARE MALFUNCTION FOR ESR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DEVICE DOES NOT RECOGNIZE 5 OUT OF 16 PATIENT SAMPLES. UNFORTUNATELY, NEITHER DO THE CONTROLS. PROBLEMS WITH THE SENSOR TECHNOLOGY OUR BSG DEVICE: BD SEDI-40 WITH SERIAL NUMBER: (B)(4) DOES NOT ALWAYS RECOGNIZE THE SAMPLE FILLING CORRECTLY. TODAY, DURING A MEASUREMENT OF 16 SAMPLES - 5X WAS DISPLAYED AS NOT FULLY CONSTANTLY FILLED SAMPLE/MONOVETTE, ALTHOUGH ALL MONOVETTES WERE CORRECTLY FILLED. CAN YOU PLEASE SEND US A REPLACEMENT DEVICE? A REPLACEMENT DEVICE IS NEEDED. THANK YOU.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SEDI-40 INSTR. DEFECTIVE, THE DEVICE EXPERIENCED HARDWARE / SOFTWARE MALFUNCTION FOR ESR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DEVICE DOES NOT RECOGNIZE 5 OUT OF 16 PATIENT SAMPLES. UNFORTUNATELY, NEITHER DO THE CONTROLS. PROBLEMS WITH THE SENSOR TECHNOLOGY OUR BSG DEVICE: BD SEDI-40 WITH SERIAL NUMBER: 00142 DOES NOT ALWAYS RECOGNIZE THE SAMPLE FILLING CORRECTLY. TODAY, DURING A MEASUREMENT OF 16 SAMPLES - 5X WAS DISPLAYED AS NOT FULLY CONSTANTLY FILLED SAMPLE/MONOVETTE, ALTHOUGH ALL MONOVETTES WERE CORRECTLY FILLED. CAN YOU PLEASE SEND US A REPLACEMENT DEVICE? A REPLACEMENT DEVICE IS NEEDED. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593998 BD SEDI-40 INSTR. DEFECTIVE ESR SYSTEM JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown