BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 601 MODULE

    MDR report key: 20634622 · Received November 7, 2024

    Report

    Report Number
    1823260-2024-03232
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 18, 2024
    Report Date
    March 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE, REPLACED THE SAMPLE PROBE, AND PERFORMED ADJUSTMENTS. HE PERFORMED MECHANICAL CHECKS WITH ACCEPTABLE RESULTS. THE CUSTOMER PERFORMED A PRECISION CHECK WITH ACCEPTABLE RESULTS. THE FSE FOUND CONTAMINATION IN THE MODULE'S SURFACES. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO CONTAMINATION OF THE ASSAY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 792358. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY HAD RECEIVED QUESTIONABLE ELECSYS ESTRADIOL III RESULTS FOR TWO DAYS FROM SEVERAL PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THE REPORTER PROVIDED TWO EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 THE INITIAL RESULT WAS 18.35 PG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 121.3 PG/ML. THE PATIENT SAMPLE WAS SENT TO ANOTHER FACILITY AND THE RESULT WAS REPORTED AS 295 PMOL/L. SAMPLE 2 THE INITIAL RESULT WAS 51.02 PG/ML. THE REPEAT RESULT WAS 104.6 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2110198 COBAS E 601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown