BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 25257321 · Received May 22, 2026

    Report

    Report Number
    1823260-2026-02030
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336220153
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALCIUM GEN.2 REAGENT LOT NUMBER WAS 920240. THE GLUCOSE HK GEN.3 REAGENT LOT NUMBER WAS 919276. THE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 REAGENT LOT NUMBER WAS 935593. THE ALANINE AMINOTRANSFERASE ACC. TO IFCC II REAGENT LOT NUMBER WAS 918221. THE TOTAL PROTEIN GEN.2 REAGENT LOT NUMBER WAS 918054. THE MAGNESIUM GEN.2 REAGENT LOT NUMBER WAS 899103. THE HDL-CHOLESTEROL GEN.4 REAGENT LOT NUMBER WAS 894019. THE CALCIUM GEN.2, GLUCOSE HK GEN.3, ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2, ALANINE AMINOTRANSFERASE ACC. TO IFCC II, TOTAL PROTEIN GEN.2, MAGNESIUM GEN.2, HDL-CHOLESTEROL GEN.4 REAGENTS' EXPIRATION DATES WERE NOT PROVIDED. THE QC WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) DETECTED AN OVERFLOW/CARRY-OVER AT THE REACTION CELLS, WHERE THE END OF THE TUBE AT THE VACUUM VESSEL WAS CRACKED, CAUSING A VACUUM LEAK. HE TRIMMED THE END OF THE TUBE, WHICH FIXED THE VACUUM LEAK. HE THEN CHECKED THE RINSE LEVELS, PERFORMED CALIBRATION AND QC, AND THEY WERE WITHIN SPECIFICATIONS. THE SERVICE ACTIONS OF TRIMMING THE END OF THE TUBE RESOLVED THE ISSUE LOCALLY. THE CAUSE OF THE EVENT WAS DUE TO A DAMAGED RINSE TUBE ON THE VACUUM VESSEL.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH CALCIUM GEN.2 ASSAY, 2 PATIENTS' SAMPLES TESTED WITH GLUCOSE HK GEN.3 ASSAY, 1 PATIENT SAMPLE TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ASSAY, ALANINE AMINOTRANSFERASE ACC. TO IFCC II ASSAY, CALCIUM GEN.2 ASSAY, TOTAL PROTEIN GEN.2 ASSAY, 1 PATIENT SAMPLE TESTED WITH MAGNESIUM GEN.2 ASSAY, 1 PATIENT SAMPLE TESTED WITH TOTAL PROTEIN ASSAY, 1 PATIENT SAMPLE TESTED WITH HDL-CHOLESTEROL GEN.4 ASSAY ON A COBAS C 303 ANALYTICAL UNIT. PATIENT 1: CALCIUM: INITIAL RESULT: 6.5 MG/DL. REPEAT RESULT: 10.0 MG/DL. PATIENT 2: GLUCOSE: INITIAL RESULT: 14.8 MG/DL. REPEAT RESULT: 96.3 MG/DL, AND THIS RESULT WAS DEEMED TO BE CORRECT. PATIENT 3: ALKALINE PHOSPHATASE: INITIAL RESULT: 56.7 U/L. REPEAT RESULT: 127 U/L. ALANINE AMINOTRANSFERASE: INITIAL RESULT: 16.7 U/L. REPEAT RESULT: 32.9 U/L. CALCIUM: INITIAL RESULT: 1.84 MG/DL (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 9.07 MG/DL. TOTAL PROTEIN: INITIAL RESULT: 3.14 G/DL. REPEAT RESULT: 5.84 G/DL. PATIENT 4: MAGNESIUM: INITIAL RESULT: 3.95 MG/DL (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 2.15 MG/DL. PATIENT 5: TOTAL PROTEIN: INITIAL RESULT: 7.60 G/DL. REPEAT RESULT: 3.34 G/DL. PATIENT 6: HDL-CHOLESTEROL: INITIAL RESULT: 63.5 MG/DL. REPEAT RESULT: 39.5 MG/DL. PATIENT 7: GLUCOSE: INITIAL RESULT: 200 MG/DL. REPEAT RESULT: 59.9 MG/DL PATIENT 8: CALCIUM: INITIAL RESULT: 6.53 MG/DL. REPEAT RESULT: 9.98 MG/DL. DATA FLAGS ACCOMPANYING OTHER TEST RESULTS PROMPTED THE REPEAT OF THE SAMPLES. "SOME" OF THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611842 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336220153

    Patients

    Seq Age Sex Outcome Treatment
    1