BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 20462508 · Received October 16, 2024

    Report

    Report Number
    1823260-2024-02990
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    September 13, 2024
    Report Date
    December 30, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PCT REAGENT LOT NUMBER WAS 755916. THE FT4 REAGENT LOT NUMBER WAS 767235. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE RACK LOADER SAMPLE POSITION. THE INSTRUMENT WAS VERIFIED AND ALL CHECKS WERE PERFORMED SUCCESSFULLY. THE ROOT CAUSE WAS DUE TO INSUFFICIENT COMPONENT ADJUSTMENT. THE SERVICE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTERWARD.

    Additional Manufacturer Narrative · 0

    THE PCT REAGENT LOT NUMBER WAS 120820. THE EXPIRATION DATE WAS NOT PROVIDED. THE FT4 REAGENT LOT NUMBER WAS 105782. THE EXPIRATION DATE WAS NOT PROVIDED. ON 13-SEP-2024 AND 14-SEP-2024, THE FSE FOUND THAT THE RACK LOADER WAS SLIGHTLY SEPARATED FROM THE INSTRUMENT COMPROMISING THE RACK SAMPLING POSITION ADJUSTMENT. HE POSITIONED THE RACK LOADER BACK INTO PLACE. HE THEN RAN TEST SAMPLES AND THEY WERE ACCEPTABLE. HE CONFIRMED THAT THE INSTRUMENT WAS PERFORMING BACK WITHIN SPECIFICATIONS. NO FURTHER ISSUES WERE OBSERVED. THE CUSTOMER MENTIONED THAT THEY RECEIVED LLD ERRORS AGAIN. ON (B)(6) 2024, THE FSE REPLACED THE SAMPLE/REAGENT PULLEY TUBING AND VERIFIED THAT THE LLD PRINTED CIRCUIT BOARD (PCB) WAS POSITIONED PROPERLY. HE ALSO FOUND THAT THE LLD VOLTAGE ON THE SAMPLE/REAGENT PROBE WAS SLIGHTLY LOWER THAN EXPECTED AND HE ADJUSTED IT TO 0.74. THE FSE THEN CHECKED ALL ADJUSTMENTS AND THEY WERE ALL WITHIN SPECIFICATIONS. HE PERFORMED CALIBRATION, QC, AND RAN TEST SAMPLES AND THEY WERE ALL ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED FOR PROCALCITONIN (PCT) AND 1 PATIENT SERUM/PLASMA SAMPLE TESTED FOR FT4 ON A COBAS E411 IMMUNOASSAY ANALYZER (RACK SYSTEM). SAMPLE 1 (PATIENT 1) WAS TESTED FOR PCT: INITIAL RESULT: 0.104 NG/ML. REPEAT RESULT: 17.03 NG/ML. SAMPLE 2 (PATIENT 2) WAS TESTED FOR FT4: INITIAL RESULT: 51.51 PMOL/L. THIS RESULT WAS CONSIDERED ABOVE THE EXPECTED RANGE (11.90 PMOL/L TO 21.60 PMOL/L). THE SAMPLE WAS THEN REPEATED ON 14-SEP-2024 AND THE REPEAT RESULT WAS 17.82 PMOL/L. THE CUSTOMER MENTIONED THAT THEY RECEIVED LIQUID LEVEL DETECTION (LLD) ERRORS ON (B)(6) 2024. THE REPEAT RESULTS WERE OBTAINED AFTER THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE ON (B)(6) 2024 AND PERFORMED TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558935 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown