BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24591154 · Received March 13, 2026

    Report

    Report Number
    1823260-2026-00902
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 17, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE FOR PATIENT 3 WAS EXTREMELY HEMOLYZED. SAMPLE PROBE ALARMS (ABNORMAL ASPIRATION) WERE OBSERVED ON THE ALARM TRACE DATA. THE FIELD SERVICE ENGINEER (FSE) FOUND AN ISSUE WITH THE PHOTOMETER LAMP. AN ISSUE WITH THE LAMP WAS CAUSING THE PHOTOMETRICS TO GO OUT OF RANGE. THE LAMP WAS REPLACED. INSTRUMENT PERFORMANCE TESTING AND QC WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FSE WAS THE ROOT CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    THE GLUC3 REAGENT LOT NUMBER WAS 88231201 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE ALTP2 REAGENT LOT NUMBER WAS 898096 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE UREAL REAGENT LOT NUMBER WAS 918138 WITH AN EXPIRATION DATE OF 30-JUN-2026. THE CA2 REAGENT LOT NUMBER WAS 894309 WITH AN EXPIRATION DATE OF 31-OCT-2026. THE TP2 REAGENT LOT NUMBER WAS 883217 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE CRP4 REAGENT LOT NUMBER WAS 869782 WITH AN EXPIRATION DATE OF 31-MAY-2026.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES AND MULTIPLE TESTS ON A COBAS C 503 ANALYTICAL UNIT. THE ANALYZER WAS ALSO PRODUCING ALARMS ASSOCIATED WITH THE PHOTOMETER OR OPTICAL PATH. DISCREPANT RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES TESTED FOR ALTP GEN.2 (ALTP2), UREA/BUN (UREAL), CALCIUM GEN.2 (CA2), GLUCOSE HK GEN.3 (GLUC3), TOTAL PROTEIN GEN.2 (TP2), AND TINA-QUANT C-REACTIVE PROTEIN IV (CRP4) . PATIENT 1: THE INITIAL ALTP2 RESULT WAS 7.7 U/L. THE REPEAT RESULT WAS 22.4 U/L. THE INITIAL UREAL RESULT WAS 14 MG/DL. THE REPEAT RESULT WAS 51.6 MG/DL. THE INITIAL CA2 RESULT WAS 3.47 MG/DL. THE REPEAT RESULT WAS 9.8 MG/DL. THE INITIAL GLUC3 RESULT WAS 48 MG/DL. THE REPEAT RESULT WAS 126 MG/DL. PATIENT 2: THE INITIAL CA2 RESULT WAS 5.0 MG/DL. THE REPEAT RESULT WAS 8.8 MG/DL. THE INITIAL CRP4 RESULT WAS 0.3 MG/DL. THE REPEAT RESULT WAS 0.493 MG/DL. THE INITIAL TP2 RESULT WAS 4.6 G/DL. THE REPEAT RESULT WAS 6.11 G/DL. THE INITIAL GLUC3 RESULT WAS 86 MG/DL. THE REPEAT RESULT WAS 119 MG/DL. PATIENT 3: THE INITIAL CA2 RESULT WAS 2.0 MG/DL. THE REPEAT RESULT WAS 6.6 MG/DL. THE INITIAL GLUC3 RESULT WAS 49.7 MG/DL. THE REPEAT RESULT WAS 132 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495370 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1