BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 801 ANALYTICAL UNIT

    MDR report key: 21738083 · Received April 1, 2025

    Report

    Report Number
    1823260-2025-00945
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 1, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K162606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HCG+B REAGENT LOT NUMBER WAS 792314 WITH AN EXPIRATION DATE OF 30-SEP-2025. QC WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER FOUND THAT THE SAMPLE PROBE WAS DEFECTIVE. HE EXCHANGED AND ADJUSTED THE SAMPLE PROBE. HE THEN PERFORMED AN INSTRUMENT CHECK AND IT WAS PERFORMING WITHIN SPECIFICATIONS. THE ROOT CAUSE WAS DUE TO AN ISSUE WITH THE SAMPLE PROBE (COMPONENT FAILURE).

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS HCG+BETA (HCG+B) ASSAY ON A COBAS E801 ANALYTICAL UNIT. THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON COBAS PURE WITH A DILUTION OF 1:100 RESULTING IN THE FOLLOWING: INITIAL RESULT: 61041 MIU/ML. 1ST REPEAT RESULT: 61092 MIU/ML. 2ND REPEAT RESULT: AROUND 71000 MIU/ML. 3RD REPEAT RESULT: 73267 MIU/ML (TESTED ON COBAS PRO WITH A DILUTION OF 1:100). THE CUSTOMER ALLEGED THAT THE RESULTS CORRESPOND TO DIFFERENT CLINICAL INTERPRETATIONS AS ACCORDING TO THE CUSTOMER'S REFERRAL VALUES, THE LOWER RESULT WAS INTERPRETED AS A HIGH-RISK PREGNANCY WHILE THE HIGHER RESULT WAS INTERPRETED AS A GOOD PREGNANCY. ALLEGEDLY, THE 1ST REPEAT RESULT OF 61092 MIU/ML WAS REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832315 COBAS E 801 ANALYTICAL UNIT IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown