BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ACCU-SED®ESR BI-LEVEL CONTROL

    MDR report key: 7967284 · Received October 15, 2018

    Report

    Report Number
    2243072-2018-01473
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 13, 2018
    Report Date
    February 7, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    GKB
    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

    THE FOLLOWING FIELD HAS BEEN UPDATED DUE TO CORRECTED INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WITH THE USE OF THE BD ACCU-SED®ESR BI-LEVEL CONTROL THERE WAS AN ISSUE WITH 7 INSTANCES OF SOFTWARE MALFUNCTION (INVALID CODE). THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ACCU-SED®ESR BI-LEVEL CONTROL THERE WAS AN ISSUE WITH 7 INSTANCES OF SOFTWARE MALFUNCTION (INVALID CODE). THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED LOT# 1823500 WAS NOT FOUND FOR THE REPORTED CATALOG NUMBER. (B)(6). 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 WITH THE USE OF THE BD ACCU-SED®ESR BI-LEVEL CONTROL THERE WAS AN ISSUE WITH SOFTWARE MALFUNCTION (INVALID CODE). THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804619 BD ACCU-SED®ESR BI-LEVEL CONTROL ESR INSTRUMENT GKB BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other