BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 IMMUNOASSAY ANALYZER

    MDR report key: 10885001 · Received November 23, 2020

    Report

    Report Number
    1823260-2020-02976
    Event Type
    Malfunction
    Date Received
    November 23, 2020
    Date of Event
    November 2, 2020
    Report Date
    January 21, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION SIGNALS WERE SLIGHTLY HIGHER THAN EXPECTED FOR SIGNAL 1 AND LOWER THAN EXPECTED FOR SIGNAL 2. THE CUSTOMER'S LEVEL 1 QC WAS WITHIN RANGE, HOWEVER, LEVEL 2 QC WAS OUTSIDE OF THE EXPECTED RANGE. THE CUSTOMER HAD NO LEVEL 2 QC RESULTS WITHIN RANGE ON THE DAY OF THE EVENT. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. LIQUID FLOW CLEANING WAS LAST PERFORMED ON (B)(6)-2020; PINCH VALVE TUBING HAD BEEN REPLACED ON (B)(6)-2020. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE SPECIFIC 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 COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TROPONIN T HS STAT (TROPONIN T HS STAT) ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL RESULT WAS 21.78 PG/ML WITH A DATA FLAG. THE REPEAT RESULT WAS 78.07 PG/ML WITH A DATA FLAG. QC WAS REPEATED WITH PASSING RESULTS AND THE SAMPLE WAS REPEATED TWICE MORE WITH RESULTS OF 77.25 PG/ML WITH A DATA FLAG AND 77.82 PG/ML WITH A DATA FLAG. IT IS NOT KNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE TROPONIN T HS STAT REAGENT LOT NUMBER WAS 45954101 WITH AN EXPIRATION DATE OF 31-JUL-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353040 COBAS E 411 IMMUNOASSAY ANALYZER IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E411 DISK NA

    Patients

    Seq Age Sex Outcome Treatment
    1