BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 402 ANALYTICAL UNIT

    MDR report key: 20955045 · Received December 17, 2024

    Report

    Report Number
    1823260-2024-03706
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 24, 2024
    Report Date
    December 27, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E 402 ANALYZER IS (B)(6). CALIBRATION AND CONTROLS WERE ACCEPTABLE. UPON REVIEW OF THE ALARM TRACE FOR (B)(6) 2024, 52 SAMPLE SHORT ALARMS AND 5 SAMPLE CLOT ALARMS WERE OBSERVED. THE FIELD SERVICE ENGINEER PERFORMED PRECISION STUDIES AND THESE RECOVERED WELL. AN INSTRUMENT CHECK WAS PERFORMED AND WAS ACCEPTABLE. THE SAMPLE PIPETTOR WAS NOT ADJUSTED WELL, SO HE ADJUSTED IT. THE ENGINEER NOTICED THAT THE SETTINGS FOR THE DETECTION OF AIR ASPIRATION WERE TURNED OFF, SO THESE SETTINGS WERE ACTIVATED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH ELECSYS TROPONIN T HS ON A COBAS PURE E 402 ANALYTICAL UNIT. THE FIRST SAMPLE FROM THE PATIENT INITIALLY RESULTED IN A TROPONIN T VALUE OF 834 PG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF < 3 PG/ML WITH A DATA FLAG. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER ON (B)(6) 2024, RESULTING IN A VALUE OF 3.01 PG/ML. THE SECOND SAMPLE FROM THE PATIENT INITIALLY RESULTED IN A TROPONIN T VALUE OF 4.96 PG/ML. THE SAMPLE WAS REPEATED ON (B)(6) 2024, RESULTING IN A VALUE OF 15 PG/ML. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER ON (B)(6) 2024, RESULTING IN A VALUE OF 13.9 PG/ML. THE CUSTOMER STATED THAT A VALUE OF 3 PG/ML FIT WITH THE PATIENT'S CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486367 COBAS E 402 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 77052801

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female HIDROFEROL| MONOLITUM| OPTOVITE B12