BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 11921830 · Received June 2, 2021

    Report

    Report Number
    1823260-2021-01628
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 16, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER CHECKED AND CORRECTED THE BASIC FUNCTIONALITY OF MULTIPLE PARTS OF THE MODULE INCLUDING THE CELL RINSE AND PIPETTING ACCURACY. CALIBRATIONS AND QC WERE ACCEPTABLE. REAGENT ISSUES WERE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) # (B)(4). THE COUNTRY OF ORIGIN IS (B)(6). FACILITY NAME: (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE CA AND GGT RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C 702 MODULE ANALYZER. SAMPLE #1 (ID: (B)(6)). THE INITIAL CA RESULT WAS 1.77 MMOL/L AND THE REPEAT RESULT WAS 2.4 MMOL/L. SAMPLE #2 (ID: (B)(6)). THE INITIAL GGT RESULT WAS < 3 U/L AND THE REPEAT RESULT WAS 51 U/L. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE ASKED FOR BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818493 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1