BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 19613467 · Received June 26, 2024

    Report

    Report Number
    1823260-2024-01858
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    June 1, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE REPLACED THE PROBE AND PERFORMED ADJUSTMENTS. HE PERFORMED CHECKS WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR 2 PATIENT SAMPLES AND QUESTIONABLE CALCIUM AND ALBUMIN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1 (ID:(B)(6): THE INITIAL GLUCOSE RESULT WAS 5 MG/DL AND THE REPEATED RESULT WAS 183 MG/DL. PATIENT 2 (ID: (B)(6); THE INITIAL CALCIUM RESULT WAS 5.5 MG/DL AND THE REPEATED RESULT WAS 9.4 MG/DL. THE INITIAL ALBUMIN RESULT WAS 1.5 G/DL AND THE REPEATED RESULT WAS 3.3 G/DL. PATIENT 3 (ID: (B)(6): THE INITIAL GLUCOSE RESULT WAS 62 MG/DL. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEATED RESULT WAS 143 MG/DL. THE REPEATED RESULTS WERE TESTED ON ANOTHER MODULE AND WERE DEEMED CORRECT. THE SAMPLES WERE REPEATED BECAUSE THE INITIAL RESULTS APPEARED LOW FOR THE PATIENTS' PROFILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702074 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown