BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 CORE UNIT

    MDR report key: 13660636 · Received March 3, 2022

    Report

    Report Number
    1823260-2022-00568
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 7, 2022
    Report Date
    March 24, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928330
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE DATA MANAGER USES THE OBSERVATION REQUEST SEGMENT (OBR) IN A RESULT REPORT MESSAGE OR A TEST SELECTION UPLOAD MESSAGE. THE HOST USES THE OBR IN A TEST SELECTION DOWNLOAD MESSAGE. AN OBR IS CREATED FOR EVERY REGULAR TEST AND EVERY COBAS E FLOW TEST. FOR A REGULAR TEST, THERE IS ONE "OBX" PER OBR. FOR A COBAS E FLOW TEST, THERE IS ONE OBR SEGMENT, WHICH HAS ONE "OBX" SEGMENT FOR THE COBAS E FLOW TEST, AND ONE "OBX" SEGMENT FOR EACH ASSOCIATED EMBEDDED TEST. THE INVESTIGATION ATTEMPTED TO REPRODUCE THE CUSTOMER'S ALLEGATION ON A VIRTUAL MACHINE WITH DATA MANAGER VERSION 1.06.09, HOWEVER, THE ISSUE COULD NOT BE REPRODUCED. A SAMPLE WHICH CONTAINED THE RESULT FOR AN HIV DUO TEST AND AN HBSAG TEST WAS SENT MANUALLY FROM THE DATA MANAGER AFTER IT WAS RECEIVED FROM THE INSTRUMENT. THE RESULT FOR EACH TEST APPLICATION WAS REPORTED WITHIN ITS OWN OBR SEGMENT ACCORDING TO THE EXPECTED BEHAVIOR. THE ISSUE WAS NO LONGER OBSERVED AT THE CUSTOMER SITE AND WAS NOT REPRODUCED AT THE INVESTIGATION SITE. THE CUSTOMER'S DATABASE WAS REQUESTED FOR INVESTIGATION, BUT COULD NOT BE PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A SOFTWARE ISSUE WITH COBAS 8000 DATA MANAGER SERIAL NUMBER (B)(4) ON A COBAS 8000 INSTRUMENT. THE ISSUE WAS NOTICED DURING THE INITIAL CONFIGURATION OF EFLOW TESTS ON THE NEW INSTRUMENT. DURING TESTING TO MAKE SURE THE CONFIGURATION WAS CORRECT, IT WAS NOTED THAT, FOR SOME SAMPLES, WHEN AN (B)(6) DUO RESULT WAS SENT AT THE SAME TIME AS ANOTHER RESULT (E.G. (B)(6)), THE (B)(6 (RESULT WAS DISPLAYED WITHIN THE (B)(6) DUO RESULT. THE DATA MANAGER USES A SPECIFIC COMMUNICATION PROTOCOL TO SEND RESULT MESSAGES TO THE HOST (COBAS INFINITY SOFTWARE). EACH TEST HAS IT¿S OWN "OBR" AND "OBX" SEGMENTS WHICH SHOW THE START AND END OF THE RESULT MESSAGES FOR EACH SPECIFIC APPLICATION. IN THIS CASE, THE (B)(6) DUO RESULT MESSAGE CONTAINING THE MEASURED AND CALCULATED RESULTS STARTED WITH THE "OBR" SEGMENT BUT ALSO HAD MULTIPLE "OBX" SEGMENTS. IN THE EXAMPLE PROVIDED, THE (B)(6) TEST SHOULD START WITH A NEW "OBR" SEGMENT, HOWEVER, IN THIS CASE IT WAS INCLUDED UNDER THE "OBR" SEGMENT OF THE (B)(6) DUO TEST. THE SOFTWARE IS CURRENTLY CONFIGURED AT THE CUSTOMER SITE TO NOT DISPLAY THE RESULTS IF THIS OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339095 COBAS 8000 CORE UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS COBAS 8000 CORE NA 04015630928330

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown