BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23791061 · Received December 12, 2025

    Report

    Report Number
    1823260-2025-05086
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 19, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION DATA WAS ACCEPTABLE. A REVIEW OF ALARM TRACE DATA SHOWED PHOTOMETER ABSORBANCE ERRORS. ASPIRATION ERRORS WERE ALSO OBSERVED, WHICH INDICATE POSSIBLE POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER FOUND A CLOGGED VALVE. THE VALVE WAS CLEANED AND THEN SUBSEQUENTLY REPLACED. REACTION CELLS WERE REPLACED. INSTRUMENT CHECKS AND PRECISION STUDIES WERE PERFORMED. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE ALK. PHOS. REAGENT LOT NUMBER WAS 907504, THE ALT REAGENT LOT NUMBER WAS 880782, THE CALCIUM REAGENT LOT NUMBER WAS 894309, THE GLUCOSE REAGENT LOT NUMBER WAS 882312, AND THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 883217. THE REAGENT EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS C 503 ANALYTICAL UNIT. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ALTP GEN.2, ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2, CALCIUM GEN.2, GLUCOSE HK GEN.3, AND TOTAL PROTEIN GEN.2. PATIENT SAMPLE 2 ALSO HAD DISCREPANT SODIUM ELECTRODE RESULTS ON A COBAS PRO ISE ANALYTICAL UNIT. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED THE SODIUM ELECTRODE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DECIDED TO REPEAT THE SAMPLES DUE TO DATA FLAGS RECEIVED FOR OTHER TESTS RESULTS FROM THE SAMPLES. PLEASE SEE ATTACHMENT FOR ALL PATIENT DATA. THE REPEAT 2 RESULTS WERE MEASURED ON A SECOND ANALYZER. THE REPEAT VALUES WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761827 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown