BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 18864547 · Received March 8, 2024

    Report

    Report Number
    1823260-2024-00702
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 8, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HGG+B REAGENT LOT NUMBER IS 70917405 WITH AN EXPIRATION DATE OF 30-SEP-2024. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND DETERMINED THE EVENT WAS CAUSED BY THE SAMPLE PROBE FITTING. HE THEN READJUSTED THE PROBE. THE FSE CONFIRMED THAT THE SYSTEM GOES INTO STANDBY WITH NO ALARMS AND THE CUSTOMER PERFORMED QC WITH ACCEPTABLE RESULTS. THE ANALYZER'S PERFORMANCE WAS VERIFIED. THE INVESTIGATION REVIEWED THE QC RECOVERY; THE QC RECOVERY WAS WITHIN THE CUSTOMER'S PROVIDED RANGES BEFORE AND AFTER THE EVENT. THE INVESTIGATION REVIEWED THE CUSTOMER'S HANDLING OF PATIENT SAMPLES; THE PATIENT SAMPLE WAS CENTRIFUGED FOR 5 MINUTES AT 3400 RPM. THE PROVIDED CENTRIFUGATION TIME IS SHORTER THAN THE TEN-MINUTE RECOMMENDED TIME FOR THE BRAND OF THE PATIENT SAMPLE TUBE USED. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG+B RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E411 DISK. THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE NURSE INFORMED THE REPORTER THAT THE PATIENT HAD A POSITIVE URINE PREGNANCY TEST, PROMPTING THE RERUN OF THE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.21 MIU/ML. THE REPEAT RESULT WAS 1754 MIU/ML. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990512 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female