BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3062855 · Received April 17, 2013

    Report

    Report Number
    1823260-2013-02333
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS NO FURTHER INFORMATION COULD BE OBTAINED. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR TOTAL PROTEIN. THE SAMPLE INITIALLY RESULTED AS 10.5 G/DL AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS REPEATED AND RESULTED AS 8.1 G/DL. THE SAMPLE WAS REPEATED A SECOND TIME ON ANOTHER INTEGRA 800 ANALYZER, RESULTING AS 8.1 G/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE EVENT. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 67316201 WITH AN EXPIRATION DATE OF 02/28/2014. THE CUSTOMER DECLINED A SERVICE VISIT STATING THAT THEY BELIEVED THE ISSUE TO BE SAMPLE SPECIFIC. THE CUSTOMER DID NOTE THAT THE SAMPLE WAS PLASMA AND THAT THE PLASMA IS CLOUDY. THE CUSTOMER RAN PRECISION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165456 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1