BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 21150684 · Received January 14, 2025

    Report

    Report Number
    1823260-2025-00139
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 23, 2024
    Report Date
    February 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2024 AND IT WAS ACCEPTABLE. THE QC RECOVERY WAS WITHIN THE CUSTOMER¿S ESTABLISHED RANGES. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE OF THE REAGENT. THE ALARM TRACE SHOWED A PREMATURE LIQUID LEVEL DETECTION (LLD) HOVERING ON THE ASSAY RACKPACK. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CAUSE OF THE EVENT WAS DUE TO A WORN SAMPLE/REAGENT PROBE TIP. THE SERVICE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    THE ACTH REAGENT LOT NUMBER WAS 77908601 WITH AN EXPIRATION DATE OF 31-AUG-2025. THE CUSTOMER MENTIONED THAT THEY HAD GRIPPER AND QC ISSUES AND THAT THEY FOUND A PROBE TIP IN THE REAGENT PACK AND ANOTHER ONE IN THE QC CUP ON THE DISK. SOME VOLTAGE ERROR ALARMS FOR THE SAMPLE/REAGENT PROBE AROUND THE TIME OF THE SAMPLES' MEASUREMENTS WERE NOTED. THE FIELD SERVICE ENGINEER FOUND THAT THE SAMPLE/REAGENT PROBE TIP WAS WORN CAUSING ISSUES WITH ASSAY TIP SECURITY. HE REPLACED THE SAMPLE/REAGENT PROBE AND PERFORMED ALIGNMENTS. HE PERFORMED A PERFORMANCE TEST AND PRECISION STUDIES AND THEY WERE WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR MULTIPLE PATIENTS' SAMPLES TESTED WITH ELECSYS ACTH ASSAY ON A COBAS E411 IMMUNOASSAY ANALYZER (DISK SYSTEM). DISCREPANT RESULTS FOR 2 PATIENTS' PLASMA SAMPLES WERE PROVIDED. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 1 PG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 161.6 PG/ML (TESTED ON ANOTHER E411). SAMPLE 2 (PATIENT 2): INITIAL RESULT: 1 PG/ML (ACCOMPANIED BY A DATA FLAG). REPEAT RESULT: 115 PG/ML (TESTED ON ANOTHER E411). THE CUSTOMER NOTICED MULTIPLE <1 PG/ML VALUES AND REPEATED THE SAMPLES. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485956 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown