BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERYTRA

    MDR report key: 23015370 · Received September 10, 2025

    Report

    Report Number
    3002772505-2025-00005
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 10, 2025
    Manufacturer
    DIAGNOSTIC GRIFOLS S.A.
    Product Code
    KSZ
    PMA / PMN Number
    BK170130
    Removal / Correction Number
    3002772505-09102025-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCORRECT RESULTS CAN BE ASSIGNED FOR AN AUTOCANCELLED AND RESCHEDULED TEST. A CORRECT RESULT IS OBTAINED FOR THE RESCHEDULED TEST WHILE NO RESULTS ARE OBTAINED FOR THE AUTO-CANCELLED ONE. THE INTERPRETATION OF THE RESCHEDULED TEST IS SHOWN IN THE RESULTS DETAIL SCREEN AND TRACEABILITY REPORT. HOWEVER, THE SYSTEM SHOWS A WRONG RESULT INTERPRETATION IN THE RESULTS SCREEN AND THIS RESULT IS SENT TO THE LIS. THE ISSUE OCCURS DUE TO A VERY RARE CONCURRENCY PROBLEM IN THE DATABASE MANAGEMENT. THREE CONDITIONS MUST BE MET TO TRIGGER THE INCIDENT: A TEST IS AUTOMATICALLY CANCELLED AND RESCHEDULED. THIS TEST IS RESCHEDULED WHILE ITS STATUS IS ALREADY RUNNING. THE SOFTWARE IS NOT ABLE TO SUCCESSFULLY DISCARD THE CANCELLED TEST. DUE TO THIS ERROR, THE TEST REMAINS INTERNALLY LINKED TO TWO DIFFERENT INSTANCES OF THE TECHNIQUE, THE CANCELLED ONE, AND THE ONE THAT IS CREATED UPON RESCHEDULING. THE MICROTUBE RESULTS FROM THE CANCELLED EXECUTION HAVE NO INFORMATION BUT THE SOFTWARE ASSIGNS A DEFAULT INTERPRETATION RESULT. THE INFORMATION CONTAINED IN THE EXECUTED INSTANCE IS CORRECT. HOWEVER, THE INTERPRETATION RESULT SHOWN IN THE RESULTS SCREEN FOR THIS TECHNIQUE IS FROM THE CANCELLED TECHNIQUE INSTANCE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT AN ABO TYPING TEST IN A CONFIRM P CARD WAS BEING EXECUTED AND IT WAS AUTOCANCELLED AS RESULT OF A REAGENT DRAWER OPENED FOR MORE THAN 3 MINUTES. AFTER THE AUTOCANCELLATION THE TEST IS RE-QUEUED AGAIN AND EXECUTED. NO RESULTS ARE OBTAINED FROM THE CANCELLED EXECUTION AND FOR THE RE-QUEUED EXECUTION THE INTERPRETATION OF THE RESULTS OBTAINED FOR EACH WELL IS A O+. THIS INTERPRETATION IS CORRECTLY SHOWN IN THE RESULTS DETAIL SCREEN AND IN THE TRACEABILITY REPORT. HOWEVER, THE SYSTEM SHOWS A WRONG RESULT INTERPRETATION O- IN THE RESULTS SCREEN AND THIS RESULT IS SENT TO THE LIS. THE LIS WARNS ABOUT A DISCREPANCY WITH PREVIOUS RESULTS OBTAINED FOR THIS SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061956 ERYTRA ERYTRA KSZ DIAGNOSTIC GRIFOLS S.A. DG-059 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown