BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 11581476 · Received March 29, 2021

    Report

    Report Number
    1823260-2021-00937
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 5, 2021
    Report Date
    April 16, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE TROPONIN REAGENT LOT EXPIRATION DATE WAS (B)(6)-2021. THE LAST CALIBRATION WAS PERFORMED ON (B)(6) 2020, THE CALIBRATION SIGNALS WERE SLIGHTLY HIGHER THAN EXPECTED. LEVEL 2 QC WAS ACCEPTABLE. LEVEL 1 QC APPEARS TO BE IN AND OUT OF 2SD AROUND THE TIME OF THE ISSUE. THE ALARM TRACE DOES NOT CONTAIN A CONSPICUOUS EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELD B3 HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS TROPONIN T HS STAT RESULT FOR ONE PATIENT WITH THE COBAS E411 IMMUNOASSAY ANALYZER. THE RESULT FROM THE FIRST TUBE WAS 118.9 PG/ML. THE INITIAL RESULT FROM THE SECOND TUBE WAS 10.02 PG/ML. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE REPEATED RESULT FROM THE SECOND TUBE WAS 117.3 PG/ML. THE SECOND REPEATED RESULT FROM THE SECOND TUBE WAS 111.4 PG/ML. THE REAGENT LOT NUMBER WAS 486252. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478110 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 RACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1