BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24752590 · Received April 1, 2026

    Report

    Report Number
    1823260-2026-01184
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 4, 2026
    Report Date
    April 29, 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 REAGENT LOT NUMBERS ARE: UREA/BUN - 918138 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 - 907504 GLUCOSE HK GEN.3 - 882312 CREATININE JAFFE GEN.2 - 898161. THE FIELD SERVICE ENGINEER INSPECTED THE ANALYZER AND DETERMINED THAT A PATIENT SAMPLE OR ASPIRATION PROBLEM MAY HAVE CAUSED THE EVENT. HE PREVENTIVELY REPLACED A SOLENOID VALVE AND CHECKED THE ADJUSTMENTS AND FLUID LEVELS. THE ANALYZER'S PERFORMANCE WAS VERIFIED WITH SUCCESSFUL PRECISION CHECKS AND CUSTOMER-RUN QCS.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE IDENTIFIED HARDWARE ISSUE CAUSED THE EVENT. THE CUSTOMER HAS NOT REPORTED ANY OTHER ISSUES AFTER THE SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE UREA/BUN, CREATININE JAFFE GEN.2, GLUCOSE HK GEN.3, AND ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ASSAY RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. UREA/BUN THE INITIAL RESULT WAS 81.7 MG/DL. THE REPEAT RESULT WAS 17.5 MG/DL. THE REPEAT RESULT WAS 17.9 MG/DL. THE THIRD REPEAT RESULT WAS 17.3 MG/DL. CREATININE THE INITIAL RESULT WAS 6.9 MG/DL. THE REPEAT RESULT WAS 1.37 MG/DL. THE REPEAT RESULT WAS 1.35 MG/DL. THE THIRD REPEAT RESULT WAS 1.46 MG/DL. GLUCOSE THE INITIAL RESULT WAS 218 MG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 92.0 MG/DL. THE SECOND REPEAT RESULT WAS 92.4 MG/DL. THE THIRD REPEAT RESULT WAS 88.3 MG/DL. ALKALINE PHOSPHATASE THE INITIAL RESULT WAS 48.1 U/L. THE FIRST REPEAT RESULT WAS 118 U/L. THE SECOND REPEAT RESULT WAS 118 U/L. THE THIRD REPEAT RESULT WAS 116 U/L. THE NURSE QUESTIONED THE (B)(6) 2026 INITIAL RESULTS BECAUSE THEY DID NOT MATCH THE PATIENT'S (B)(6) 2026 MORNING DRAW RESULTS, PROMPTING FIRST AND SECOND RERUNS ON (B)(6) 2026 WITH THE REPORTED ANALYZER AND A THIRD RERUN ON (B)(6) 2026 WITH ANOTHER COBAS ANALYZER. THE REPEAT RESULTS WERE DEEMED CORRECT AND MATCHED THE (B)(6) 2026 MORNING DRAW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18723 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male "ACETAMINOPAN"| ASPIRIN| CARBIDOPA-LEVODOPA| HEPARIN INJECTION| MELATONIN| MEMATINE| MIDOCRINE| QUETIAPINE