BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 7867967 · Received September 12, 2018

    Report

    Report Number
    1823260-2018-03092
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 20, 2018
    Report Date
    September 12, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). NA.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY AND THE ELECSYS FT4 II ASSAY ON A COBAS 8000 E 801 MODULE. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO ALARMS WERE ISSUED UPON THE INITIAL RUN OF THE SAMPLE. THE SAMPLE INITIALLY RESULTED WITH A TSH VALUE OF 0.0268 MIE/L AND REPEATED AS 4.63 MIE/L. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING WITH A TSH VALUE OF 5.02 MIE/L. THE SAMPLE INITIALLY RESULTED WITH A FT4 VALUE OF 1.17 PMOL/L AND REPEATED AS 16.9 PMOL/L. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER, RESULTING WITH A FT4 VALUE OF 16.3 PMOL/L. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE TSH REAGENT LOT NUMBER WAS 33181400 AND THE FT4 REAGENT LOT NUMBER WAS 30320300. THE REAGENT EXPIRATION DATES WERE ASKED FOR, BUT NOT PROVIDED. CALIBRATION AND CONTROLS TESTED FOR TSH AND FT4 WERE OK. BASED ON THIS DATA, A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. UPON REVIEW OF THE ALARM TRACE, SEVERAL ABNORMAL PROBE ASPIRATION ALARMS OCCURRED ON THE MORNING OF THE DATE OF THE EVENT. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710967 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1