BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 12191648 · Received July 19, 2021

    Report

    Report Number
    1823260-2021-02093
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Date of Event
    June 25, 2021
    Report Date
    August 12, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION SIGNALS WERE WITHIN EXPECTATIONS. THE SECOND LEVEL OF CALIBRATOR HAD SIGNALS THAT TENDED TO BE LOWER. QUALITY CONTROL RECOVERY ON (B)(6) 2021 AND 28-JUN-2021 WAS WITHIN RANGE. THE CUSTOMER USED 13 MM. DIAMETER TUBES, BUT DID NOT USE RACK ADAPTERS REQUIRED FOR 13 MM. DIAMETER TUBES. THE SAMPLE TUBE WAS NOT INVERTED AS MANY TIMES AS RECOMMENDED BY THE TUBE MANUFACTURER. THE SAMPLE CLOTTING TIME WAS SHORTER THAN RECOMMENDED BY THE TUBE MANUFACTURER. THE INVESTIGATION DETERMINED THE ISSUE WAS CAUSED BY INCORRECT PRE-ANALYTIC SAMPLE HANDLING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS HCG TEST SYSTEM VER. 2 ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE SAMPLE INITIALLY RESULTED IN AN HCG VALUE OF > 10000 MUI/ML. THE SAMPLE WAS REPEATED AFTER DILUTING 1:100, RESULTING IN A VALUE OF 49655 MUI/ML. THE 49655 MUI/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. ON (B)(6) 2021, THE SAMPLE WAS REPEATED, RESULTING IN AN HCG VALUE OF 3512 MUI/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE PATIENT. THE SAMPLE WAS REPEATED AGAIN ON (B)(6) 2021, RESULTING IN A VALUE OF 184.9 MUI/ML. THE SAMPLE WAS REPEATED A SECOND TIME ON (B)(6) 2021, RESULTING IN A VALUE OF 47197 MUI/ML. THE 47197 MUI/ML VALUE WAS COMPATIBLE WITH THE PATIENT'S CONDITION AS THE PATIENT WAS PREGNANT. THE 47197 MUI/ML VALUE ALSO AGREED WITH ULTRASOUND PERFORMED ON THE PATIENT. THE HCG REAGENT LOT NUMBER WAS 528065.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090594 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR