BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 3684851 · Received March 18, 2014

    Report

    Report Number
    1823260-2014-01860
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + THE SS-SUBUNIT (HCG+SS) RESULTS FOR THREE PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 50.97 MUI/ML. THE REPEAT RESULT WAS 0.1 MUI/ML TWICE. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. PATIENT 2 WAS A (B)(6) YEAR OLD FEMALE. THE INITIAL RESULT WAS 0.773 MUI/ML. THE REPEAT RESULTS WERE 2.21 MUI/ML AND 1.0 MUI/ML. THE RESULT OF 1.0 MUI/ML WAS REPORTED OUTSIDE THE LABORATORY. A NEW SAMPLE COLLECTED FOR THIS PATIENT GAVE A RESULT OF 1.0 MUI/ML. THE SPECIFIC DATE WAS NOT PROVIDED. PATIENT 3 WAS A (B)(6) YEAR OLD FEMALE. ON (B)(6) 2014, THE INITIAL RESULT WAS 6.48 MUI/ML. THE REPEAT RESULT WAS 0.1 MUI/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THERE WERE NO ADVERSE EVENTS. THE HCG+SS REAGENT LOT NUMBER WAS 173268. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. DURING A SERVICE VISIT, IT WAS NOTED THAT THE PINCH TUBES WERE A LITTLE BIT DAMAGED SO THEY WERE EXCHANGED. SOME SAMPLE RACKS DID NOT HAVE THE RECOMMENDED RACK ADAPTERS. REVIEW OF THE PROVIDED CALIBRATION AND QC DATA DID NOT INDICATE A REAGENT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158776 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER DHA ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 034 YR