BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 7237231 · Received February 2, 2018

    Report

    Report Number
    1823260-2018-00311
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 14, 2018
    Report Date
    February 2, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS HCG + BETA TEST SYSTEM (HCGB) ON A COBAS E 411 IMMUNOASSAY ANALYZER (E411). IT WAS ASKED, BUT IT IS NOT KNOWN IF THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 0.529 MIU/ML. THE REAGENT PACK HAD TWO TESTS LEFT IN IT AT THE TIME OF TESTING. THE RESULT FROM THE NEXT SAMPLE THAT WAS TESTED WAS OK. THE REAGENT PACK WAS REPLACED AND THE COMPLAINED SAMPLE WAS REPEATED TWICE, EACH TIME RESULTING AS > 10000 MIU/ML ACCOMPANIED BY A DATA FLAG. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE HCGB REAGENT LOT NUMBER WAS 210151. THE REAGENT EXPIRATION DATE WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER AND COULD FIND NO PROBABLE CAUSE FOR THE ISSUE. QUALITY CONTROL PRECISION FOR HCGB WAS VERY GOOD. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80805 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA

    Patients

    Seq Age Sex Outcome Treatment
    1