BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 9976863 · Received April 20, 2020

    Report

    Report Number
    1823260-2020-01053
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 26, 2020
    Report Date
    May 12, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC INFORMATION WERE REQUESTED BUT NOT PROVIDED. BASED ON THE AVAILABLE DATA, THE INVESTIGATION DID NOT IDENTIFY A GENERAL INSTRUMENT OR REAGENT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE LOW ELECSYS TROPONIN T HS RESULT FOR ONE PATIENT FROM A COBAS 8000 E 801 MODULE. THE CUSTOMER PERFORMED TESTING ON TWO PATIENT SAMPLES TUBES THAT WERE COLLECTED AT THE SAME DRAW. ON (B)(6) 2020, THE PATIENT¿S FIRST SAMPLE DID NOT GENERATE A RESULT DUE TO AN INSTRUMENT ALARM. THE PATIENT'S SECOND SAMPLE HAD AN INITIAL TROPONIN RESULT OF 12.1 NG/L. THE RESULT OF 12.1 NG/L WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2020, THE CUSTOMER TRANSFERRED THE PATIENT¿S FIRST SAMPLE AND SECOND SAMPLE INTO SEPARATE SAMPLE CUPS AND PERFORMED REPEAT TESTING. THE FIRST SAMPLE HAD REPEAT TROPONIN RESULTS OF 116 NG/L AND 117 NG/L. THE SECOND SAMPLE HAD REPEAT TROPONIN RESULTS OF 116 NG/L AND 117 NG/L PERFORMED ON A DIFFERENT ANALYZER. TROPONIN REAGENT LOT NUMBER USED FOR PATIENT TESTING WAS 429178 WITH AN EXPIRATION DATE OF 31-JAN-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442230 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA

    Patients

    Seq Age Sex Outcome Treatment
    1