BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 5959336 · Received September 19, 2016

    Report

    Report Number
    1823260-2016-01400
    Event Type
    Malfunction
    Date Received
    September 19, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 19, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT. THE INITIAL RESULT WAS >10000 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:100 DILUTION AND THE RESULT WAS 260.2 MIU/ML WITH A DATA FLAG. THE CUSTOMER CHECKED THE SAMPLE INTEGRITY AND NO CLOT WAS FOUND. THE SAMPLE WAS RETESTED AND THE RESULT WAS >10000 MIU/ML WITH A DATA FLAG. THE CUSTOMER ATTEMPTED TO REPEAT THE SAMPLE WITH A 1:100 DILUTION BUT THE CUSTOMER RECEIVED NO NUMERIC VALUE AND AN ALARM MESSAGE STATING THAT THE DILUENT WAS TOO SHORT. THE CUSTOMER NOTED THAT THE DILUENT HAD 36 TESTS LEFT. THE CUSTOMER LOADED A NEW DILUENT AND THE SAMPLE WAS REPEATED WITH A RESULT OF >10000 MIU/ML WITH A DATA FLAG. THE SAMPLE WAS REPEATED WITH A 1:100 DILUTION AND THE RESULTS WERE 100344 MIU/ML WITH A DATA FLAG AND 103046 MIU/ML WITH A DATA FLAG. THE RESULT OF 100344 MIU/ML WAS BELIEVED TO BE CORRECT. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 13196003 WITH AN EXPIRATION DATE OF 05/31/2017. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE AND COULD NOT DUPLICATE THE PROBLEM. AS PREVENTATIVE MEASURE, HE REPLACED THE PROBE AND RAN PERFORMANCE TESTING WITH RESULTS WITHIN SPECIFICATIONS. FURTHER INVESTIGATION COULD NOT IDENTIFY A SPECIFIC ROOT CAUSE. BASED ON THE ALARM RECEIVED BY THE CUSTOMER, THE MOST LIKELY ROOT CAUSE WAS ASSUMED TO BE AN ISSUE SUCH AS BUBBLES WITH THE DILUENT. A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. BASED ON THE PROVIDED PERFORMANCE DATA, AN INSTRUMENT ISSUE WAS NOT LIKELY THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613669 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR