BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 14642844 · Received June 9, 2022

    Report

    Report Number
    1823260-2022-01676
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    April 10, 2022
    Report Date
    August 5, 2022
    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
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED NEW QUESTIONABLE RESULTS: ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 15.8 NG/L. THE FIRST REPEAT RESULT WAS 6.69 NG/L. THE SECOND REPEAT RESULT WAS 6.86 NG/L. THE INITIAL TNT STAT RESULT WAS 6.59 NG/L. THE FIRST REPEAT RESULT WAS 6.25 NG/L. THE SECOND REPEAT RESULT WAS 6.53 NG/L. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 14.7 NG/L. THE FIRST REPEAT RESULT WAS 7.05 NG/L. THE SECOND REPEAT RESULT WAS 7.13 NG/L. THE INITIAL TROPONIN T STAT RESULT WAS 8.99 NG/L. THE FIRST REPEAT RESULT WAS 7.06 NG/L. THE SECOND REPEAT RESULT WAS 7.01 NG/L. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 70.9 NG/L. THE FIRST REPEAT RESULT WAS 9.88 NG/L. THE SECOND REPEAT RESULT WAS 10.5 NG/L. THE INITIAL TNT STAT RESULT WAS 9.13 NG/L. THE FIRST REPEAT RESULT WAS 10.3 NG/L. THE SECOND REPEAT RESULT WAS 10.4 NG/L. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 28 NG/L. THE FIRST REPEAT RESULT WAS 18.3 NG/L. THE SECOND REPEAT RESULT WAS 18 NG/L. THE INITIAL TNT STAT RESULT WAS 19.6 NG/L. THE FIRST REPEAT RESULT WAS 17.7 NG/L. THE SECOND REPEAT RESULT WAS 18 NG/L. THE INVESTIGATION ANALYZED THE PROVIDED SAMPLE FOAM DETECTION (SFD) IMAGES FROM THE MODULE'S CAMERA AND NOTED THAT 27% OF THE SAMPLES HAD FIBRIN OR OTHER SAMPLE QUALITY CONCERN THAT WAS ASPIRATED AND THEN CONTAMINATED THE ANALYZER, AFFECTING THE VOLUME OF THE SAMPLE BEING ASPIRATED. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS TROPONIN T HS ASSAY AND ELECSYS TROPONIN T STAT ASSAY RESULTS FOR 5 PATIENT SAMPLES TESTED ON THE COBAS E 801 MODULE. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 10.8 NG/L. THE FIRST REPEAT RESULT WAS 4.39 NG/L. THE SECOND REPEAT RESULT WAS 4.34 NG/L. THE INITIAL TROPONIN T STAT RESULT WAS 4.5 NG/L. THE FIRST REPEAT RESULT WAS 5.54 NG/L. THE SECOND REPEAT RESULT WAS 5.31 NG/L. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T STAT RESULT OF 10.9 NG/L. THE FIRST REPEAT RESULT WAS 4 NG/L. THE SECOND REPEAT RESULT WAS 3.6 NG/L. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 14 NG/L. THE FIRST REPEAT RESULT WAS 10.8 NG/L. THE SECOND REPEAT RESULT WAS 10.8 NG/L. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 15.6 NG/L. THE FIRST REPEAT RESULT WAS 12.5 NG/L. THE SECOND REPEAT RESULT WAS 13.1 NG/L. ON (B)(6) 2022, SAMPLE ID (B)(6) HAD AN INITIAL TROPONIN T HS RESULT OF 16 NG/L. THE FIRST REPEAT RESULT WAS 11.6 NG /L. THE SECOND REPEAT RESULT WAS 11.3 NG/L. THE INITIAL TROPONIN T STAT RESULT WAS 12.6 NG/L. THE FIRST REPEAT RESULT WAS 11.7 NG/L. THE SECOND REPEAT RESULT WAS 10.5 NG/L. THE TROPONIN T HS AND TROPONIN T STAT REAGENT LOT NUMBERS WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054813 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E801 NA 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown