BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 20515906 · Received October 23, 2024

    Report

    Report Number
    1823260-2024-03054
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 28, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANTI-TPO REAGENT LOT NUMBER IS 791515 AND THE ANTI-TG REAGENT LOT NUMBER IS 768452. THE EXPIRATION DATES WERE NOT PROVIDED. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) FOUND CRYSTALS AROUND THE ANALYZER GRIPPER AND IN THE INCUBATOR. THE FSE REPLACED THE GRIPPER. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION NOTED THAT SOME SAMPLES SEEMED TO HAVE FILM, DROPLETS, AIR BUBBLES AND WERE INSUFFICIENT IN VOLUME. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH CONTAMINATION ISSUES (BLUE PARTICLES). BASED ON THE INFORMATION PROVIDED, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO AND ROCHE DIAGNOSTICS ELECSYS ANTI-TG RESULTS FOR 7 PATIENT SAMPLES ON A COBAS E 801 MODULE. FOR SAMPLE 1, THE INITIAL ANTI-TPO RESULT WAS 36 IU/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 114 IU/ML AND 80 UI/ML. FOR SAMPLE 2, THE INITIAL ANTI-TPO RESULT WAS 50 IU/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 10 IU/ML AND < 9 UI/ML. FOR SAMPLE 3, THE INITIAL ANTI-TPO RESULT WAS 49 IU/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 10 IU/ML AND < 9 UI/ML. FOR SAMPLE 4, THE INITIAL ANTI-TPO RESULT WAS 59 IU/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 13 IU/ML AND 13 UI/ML. FOR SAMPLE 5, THE INITIAL ANTI-TPO RESULT WAS 36 IU/ML AND THE INITIAL ANTI-TG RESULT WAS 31 IU/ML. THE SAMPLE WAS REPEATED TWICE. THE ANTI-TPO RESULTS WERE 11 IU/ML AND 14 UI/ML AND THE ANTI-TG RESULTS WERE 15 IU/ML AND 17 UI/ML. FOR SAMPLE 6, THE INITIAL ANTI-TPO RESULT WAS 96 IU/ML AND THE INITIAL ANTI-TG RESULT WAS 30 IU/ML. THE SAMPLE WAS REPEATED TWICE. THE ANTI-TPO RESULTS WERE 33 IU/ML AND 32 UI/ML AND THE ANTI-TG RESULTS WERE 14 IU/ML AND 16 UI/ML. FOR SAMPLE 7, THE INITIAL ANTI-TPO RESULT WAS 62 IU/ML AND THE INITIAL ANTI-TG RESULT WAS 29 IU/ML. THE SAMPLE WAS REPEATED TWICE. THE ANTI-TPO RESULTS WERE 11 IU/ML AND 10 UI/ML AND THE ANTI-TG RESULTS WERE 15 IU/ML AND 15 UI/ML. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33245 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown