BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOAT

    MDR report key: 18007436 · Received October 25, 2023

    Report

    Report Number
    1823260-2023-03428
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 5, 2023
    Report Date
    December 11, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DER
    UDI-DI
    07613336133521
    PMA / PMN Number
    K013249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QUALITY CONTROLS RECOVERED WITHIN RANGE. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. THE FIELD SERVICE ENGINEER RAN PRECISION STUDIES AND THESE RECOVERED WITHIN GUIDELINES. AN INSTRUMENT CHECK WAS PERFORMED AND IT RECOVERED WITHIN SPECIFICATIONS. FREQUENT ABNORMAL ASPIRATION ERRORS WERE OBSERVED ON THE ALARM TRACE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE C 503 ANALYZER IS (B)(6). THE FIELD SERVICE ENGINEER RAN PRECISION STUDIES AND THESE RECOVERED WITHIN GUIDELINES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH APOAT (APOLIPOPROTEIN A) ON A COBAS PRO C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN APOLIPOPROTEIN A VALUE OF 94 MG/DL. THE VALUE WAS CONSIDERED VERY HIGH SO THE SAMPLE WAS REPEATED. THE REPEAT APOLIPOROTEIN A RESULT WAS 45 MG/DL. THE SAMPLE WAS ALSO REPEATED TWICE ON A SECOND ANALYZER ON (B)(6) 2023, RESULTING IN APOLIPOROTEIN A VALUES OF 36 MG/DL AND 36 MG/DL. THE RESULTS FROM THE SECOND ANALYZER WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926412 APOAT ALPHA-1-LIPOPROTEIN IMMUNOLOGICAL TEST SYSTEM DER ROCHE DIAGNOSTICS 705510 07613336133521

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown