BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 602 MODULE

    MDR report key: 11237996 · Received January 27, 2021

    Report

    Report Number
    1823260-2021-00273
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    December 25, 2020
    Report Date
    February 17, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D4, SERIAL NUMBER WAS UPDATED. CALIBRATION SIGNALS WERE SLIGHTLY LOWER THAN EXPECTED. QC WAS ACCEPTABLE. MULTIPLE ABNORMAL SAMPLE ASPIRATION ERRORS WERE OBSERVED ON THE ALARM TRACE DATA. THESE ERRORS SUGGEST POSSIBLE POOR SAMPLE QUALITY. THE FIELD SERVICE ENGINEER (FSE) PERFORMED INSTRUMENT TESTING WHICH SHOWED AN ISSUE. THE FSE ADJUSTED THE SAMPLE PROBE AND CHECKED THE SAMPLE PROBE LIQUID LEVEL DETECTION (LLD). THE FSE FOUND NO ISSUES WITH THE SAMPLE PROBE. NEITHER A GENERAL INSTRUMENT OR REAGENT ISSUE WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE SAMPLE PROBE AND CHECKED LIQUID LEVEL DETECTION (LLD). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS HCG + B (HCG + B) ON A COBAS 8000 E 602 MODULE. THE INITIAL RESULT WAS 32.51 MIU/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS NOT TREATED BASED ON THIS RESULT. ON (B)(6) 2021 A NEW SAMPLE WAS OBTAINED AND THE RESULT WAS 110291 MIU/ML. ON (B)(6) 2021, THE CUSTOMER REPEATED THE ORIGINAL SAMPLE AND THE RESULT WAS 10000 MIU/ML WITH A DATA FLAG. THE REPEAT WITH 1:100 DILUTION WAS 13216 MIU/ML. THE HCG + B REAGENT LOT NUMBER WAS 45406000 WITH AN EXPIRATION DATE OF 31-MAY-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135860 COBAS 8000 E 602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E602 NA

    Patients

    Seq Age Sex Outcome Treatment
    1