BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 20579266 · Received October 31, 2024

    Report

    Report Number
    1823260-2024-03153
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 11, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2024 AND THIS CALIBRATION FAILED. CALIBRATION WAS PERFORMED LATER AGAIN THAT DAY AND WAS ACCEPTABLE. QUALITY CONTROLS WERE ACCEPTABLE ON THE DAY OF THE EVENT. UPON REVIEW OF THE ALARM TRACE, MULTIPLE ABNORMAL ASPIRATION ALARMS WERE OBSERVED. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER DETERMINED THAT A SAMPLE PROBE WAS FAILING AND THE RINSE MECHANISM WAS OVERFLOWING. THE PROBE WAS REPLACED AND THE RINSE NOZZLE VOLUMES WERE CORRECTED. PRECISION STUDIES WERE PERFORMED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER WAS 803015. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR (B)(4) PATIENT SAMPLE TESTED WITH CALCIUM GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 5.5 MG/DL. THE CUSTOMER QUESTIONED THE RESULT SINCE IT DID NOT AGREE WITH THE PATIENT'S CLINICAL CONDITION AND DID NOT MATCH THE PATIENT'S HISTORY. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER, RESULTING IN A CALCIUM VALUE OF < 0.8 MG/DL WITH A DATA FLAG. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 8.0 MG/DL. THE VALUE OF 8.0 MG/DL WAS DEEMED CORRECT AND WAS REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2011499 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male