BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 RACK

    MDR report key: 13117268 · Received December 30, 2021

    Report

    Report Number
    1823260-2021-03922
    Event Type
    Malfunction
    Date Received
    December 30, 2021
    Date of Event
    December 8, 2021
    Report Date
    February 18, 2022
    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
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION TRACE DID NOT INDICATE AN ISSUE. THE QC WAS NOTED TO BE WITHIN 3 SD. THE PRE-ANALYTICAL DATA WAS REQUESTED BUT NOT PROVIDED. THE ALARM TRACE DID NOT INDICATE AN ISSUE. THE FIELD SERVICE ENGINEER (FSE) PERFORMED A BLANK CELL CALIBRATION AND SYSTEM VOLUME CHECK WITH ACCEPTABLE RESULTS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS HCG + BETA TEST SYSTEM RESULT FOR ONE PATIENT SAMPLE TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE FIRST REPEAT RESULT IS FROM THE ORIGINAL SAMPLE. THE SECOND REPEAT RESULT WAS FROM A DILUTED SAMPLE. THE INITIAL RESULT AT 12:16 PM WAS 22.27 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT OF THE ORIGINAL SAMPLE AT 12:56 PM WAS 10000 MIU/ML WITH A DATA FLAG. THE REPEAT RESULT OF THE DILUTED SAMPLE AT 12:56 PM WAS 193344 MIU/ML WITH A DATA FLAG. THE REAGENT LOT NUMBER IS 55103601 WITH AN EXPIRATION DATE OF 31-OCT-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016398 COBAS E 411 RACK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 Female