BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN/TOTAL PROTEIN STAT

    MDR report key: 20267674 · Received September 20, 2024

    Report

    Report Number
    1823260-2024-02721
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 10, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEK
    UDI-DI
    04015630918928
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE FIELD APPLICATION SPECIALIST VERIFIED THAT CALIBRATION AND CONTROLS WERE ACCEPTABLE. PRECISION STUDIES WERE PERFORMED AND RECOVERED WITHIN SPECIFICATIONS. A COMPARISON EXPERIMENT WAS PERFORMED USING MIXED AND CENTRIFUGED SAMPLES; NO OBSERVABLE DIFFERENCE WAS NOTED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE C501 MODULE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) CHECKED MULTIPLE PARTS OF THE INSTRUMENT AND NO ISSUES WERE IDENTIFIED. PRECISION CHECKS WERE WITHIN SPECIFICATION. AN ABNORMAL PROBE-SUCKING ALARM WAS OBSERVED ON THE DAY OF THE EVENT. THE PATIENT SAMPLES IN QUESTION WERE PIPETTED BEFORE AND AFTER THIS ALARM. NO ISSUES WERE OBSERVED DURING A REVIEW OF THE REACTION MONITOR DATA. THE HARDWARE PERFORMANCE CHECK (HPC) WAS WITHIN SPECIFICATION. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PRE-ANALYTICAL HANDLING ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH TOTAL PROTEIN/TOTAL PROTEIN STAT ON A COBAS 6000 C501 MODULE. THE SAMPLES WERE REPEATED THE NEXT DAY AS THE LOW VALUES DID NOT MATCH THE PREVIOUS RESULTS OF THE PATIENTS. THE FIRST SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 7.21 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 8.65 G/DL, 8.65 G/DL, AND 8.89 G/DL. THE SECOND SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 3.77 G/DL WITH A DATA FLAG AND 3.85 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 6.49 G/DL AND 6.32 G/DL. THE THIRD SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 3.07 G/DL WITH A DATA FLAG, 3.07 G/DL, AND 3.13 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 7.37 G/DL AND 7.09 G/DL. THE FOURTH SAMPLE INITIALLY RESULTED IN TOTAL PROTEIN VALUES OF 1.78 G/DL WITH A DATA FLAG AND 1.91 G/DL. THE SAMPLE WAS REPEATED, RESULTING IN VALUES OF 6.34 G/DL, 6.57 G/DL, AND 6.40 G/DL. THE PATIENTS' RESULTS WERE AMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497098 TOTAL PROTEIN/TOTAL PROTEIN STAT BIURET (COLORIMETRIC), TOTAL PROTEIN CEK ROCHE DIAGNOSTICS 771915 04015630918928

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown