BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 20623955 · Received November 6, 2024

    Report

    Report Number
    1823260-2024-03215
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM REAGENT LOT NUMBER IS 803015 AND THE MAGNESIUM REAGENT LOT NUMBER IS 788195. THE EXPIRATION DATES WERE NOT PROVIDED. THE QC RESULTS WERE ACCEPTABLE. THE CALIBRATION FOR CALCIUM WAS ACCEPTABLE. THE CALIBRATION FOR MAGNESIUM WAS NOT PROVIDED. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE ALARM TRACE SHOWED ABNORMAL SAMPLE ASPIRATION ALARMS, WHICH ARE INDICATIVE OF POOR SAMPLE QUALITY. THE FIELD SERVICE REPRESENTATIVE FOUND THE SAMPLE PROBE WAS CONTAMINATED. HE VALIDATED THE CELL RINSE VOLUME, CLEANED THE WASHING STATION, CLEANED THE SAMPLE PROBE, AND FLUSHED THE SAMPLE LINE. HE PERFORMED TESTS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 AND ROCHE DIAGNOSTICS MAGNESIUM REAGENT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL CALCIUM RESULT WAS 5.8 MG/DL AND THE REPEATED RESULT WAS 7.5 MG/DL. THE INITIAL MAGNESIUM RESULT WAS <0.5 MG/DL AND THE REPEATED RESULT WAS 1.5 MG/DL. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED DUE TO THE INITIAL RESULTS BEING LOW. THE REPEATED RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999007 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown