BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23821228 · Received December 16, 2025

    Report

    Report Number
    1823260-2025-05138
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 24, 2025
    Report Date
    January 9, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUCOSE REAGENT LOT NUMBER WAS 88231201 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE CALCIUM REAGENT LOT NUMBER WAS 861168. THE EXPIRATION DATE WAS NOT PROVIDED. THE PHOSPHATE (INORGANIC) REAGENT LOT NUMBER WAS 861343. THE EXPIRATION DATE WAS NOT PROVIDED. THE PROVIDED DATA SHOWED MULTIPLE SAMPLE ASPIRATION S1 ALARMS THAT HAD BEEN OCCURRING INTERMITTENTLY FOR THE WEEK BEFORE THE EVENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER'S FLUIDIC AND MECHANICAL SYSTEMS. HE FOUND THAT THE SAMPLE PROBE WAS CLOGGED AND DEGRADED, AND THE RINSE VOLUMES REQUIRED ADJUSTMENT. THE FSE REPLACED AND ADJUSTED THE SAMPLE PROBE, PERFORMED GEAR PUMP ADJUSTMENT, AND VERIFIED AND ADJUSTED ALL CELL RINSE VOLUMES. PRECISION STUDIES USING THE PATIENT SAMPLE AND HARDWARE VERIFICATION WERE PERFORMED, AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE QC RECOVERY WAS WITHIN THE RANGES. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE CUSTOMER DID NOT FOLLOW THE TUBE MANUFACTURER'S RECOMMENDED CENTRIFUGATION TIME. A HARDWARE CHECK, PRECISION STUDIES, AND QC WERE PERFORMED, AND THEY WERE WITHIN SPECIFICATIONS. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE FIELD SERVICE ENGINEER RESOLVED THE ISSUE. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS DUE TO A DEGRADED SAMPLE PROBE.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 ASSAY, CALCIUM GEN.2 ASSAY, AND PHOSPHATE (INORGANIC) VER.2 ASSAY ON A COBAS C 503 ANALYTICAL UNIT. GLUCOSE: INITIAL RESULT: 13 MG/DL. REPEAT RESULT: 101 MG/DL. CALCIUM: INITIAL RESULT: 6.1 MG/DL. REPEAT RESULT: 7.45 MG/DL. PHOSPHATE (INORGANIC): INITIAL RESULT: 1.3 MG/DL. REPEAT RESULT: 2.26 MG/DL. THE INITIAL RESULTS DID NOT MATCH THE PATIENT'S MEDICAL HISTORY, AND THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS C 503 ANALYTICAL UNIT. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. REPORTEDLY, AN AMENDED REPORT WITH THE CORRECT RESULTS WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50528 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male