BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 24886110 · Received April 15, 2026

    Report

    Report Number
    1823260-2026-01430
    Event Type
    Malfunction
    Date Received
    April 15, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    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

    THE ELECSYS HCG STAT REAGENT LOT NUMBER IS 869013, WITH AN EXPIRATION DATE OF 31-OCT-2026. THE FIELD APPLICATIONS SPECIALIST (FAS) INSPECTED THE ANALYZER REAGENTS, THE ONBOARD REAGENTS, THE DILUENTS, BEAD MIXER, WASH AND RINSE STATIONS, SAMPLE DISKS, SIPPER PROBE, SAMPLE AND REAGENT PROBES' DRYING CYLINDER, SYRINGES, PROBES, SYSTEM WATER, CALIBRATIONS, AND QCS. THE FAS INSPECTED PATIENT SAMPLE 3, AND NO ISSUES WERE FOUND. THIS PATIENT SAMPLE WAS RERUN, AND THE RESULT WAS 38905 MIU/ML, WHICH CORRELATED WITH THE REPORTED RESULT. THE FAS NOTED THAT THE CUSTOMER USES A 1:20 DILUTION FACTOR. PRODUCT LABELING STATES, "DILUTION - SAMPLES WITH HCG CONCENTRATIONS ABOVE THE MEASURING RANGE CAN BE DILUTED WITH DILUENT UNIVERSAL 2. THE RECOMMENDED DILUTION IS 1:100 (EITHER AUTOMATICALLY BY THE ANALYZERS OR MANUALLY). THE CONCENTRATION OF THE DILUTED SAMPLE MUST BE > 100 MIU/ML. THE FIELD SERVICE ENGINEER (FSE) PERFORMED MECHANICAL AND INSTRUMENT CHECKS. HE VERIFIED THE ALIGNMENTS OF THE SAMPLE AND REAGENT PROBES, THE SIPPER, AND THE BEAD MIXER. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG STAT ASSAY RESULTS FOR THREE PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). PATIENT SAMPLE 1 ON (B)(6) 2026: THE INITIAL RESULT WAS 193365 MIU/ML WITH A DATA FLAG. ON (B)(6) 2026: THE INITIAL RESULT WAS 151608 MIU/ML WITH A DATA FLAG. THE PATIENT UNDERWENT A SCAN FOR THREATENED ABORTION AND RESULT CORRELATION. THE PATIENT'S SCAN SHOWED A FETUS WITH A HEALTHY HEARTBEAT. PATIENT SAMPLE 2 ON (B)(6) 2026: THE INITIAL RESULT WAS 444.9 MIU/ML WITH A DATA FLAG. THE PATIENT QUESTIONED THE RESULT AS IT DID NOT MATCH HER CLINICAL PICTURE, AND THE HCG BETA RESULT FROM A COMPETITOR ANALYZER WAS 114000 MIU/ML. ON (B)(6) 2026: THE REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:100 DILUTION WAS 121754 MIU/ML WITH A DATA FLAG. ON THE FIELD SERVICE ENGINEER'S (FSE) INITIAL SERVICE VISIT, HE INSPECTED THE ANALYZER AND PERFORMED MECHANICAL AND INSTRUMENT CHECKS. HE VERIFIED THE CONDITIONS AND ALIGNMENT OF THE PARTS, INCLUDING THE PROBES AND THE MIXER. ON HIS FOLLOW-UP SERVICE VISIT, HE REVIEWED THE QC GRAPHS, PROFICIENCY RESULTS, AND THE ANALYZER LOGS. PATIENT SAMPLE 3 ON (B)(6) 2026: THE INITIAL RESULT WAS >10000 MIU/ML WITH A DATA FLAG. THE FIRST REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:20 DILUTION WAS 37663 MIU/ML WITH A DATA FLAG. THE SECOND REPEAT RESULT WITH THE PATIENT SAMPLE AT 1:20 DILUTION WAS 39491 MIU/ML WITH A DATA FLAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502275 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1