BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 11734075 · Received April 27, 2021

    Report

    Report Number
    1823260-2021-01267
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 27, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER (UDI) #(B)(4). THE COUNTRY OF ORIGIN IS (B)(6). SERVICE MAINTENANCE HAD BEEN PERFORMED RECENTLY. THE FIELD SERVICE ENGINEER CHANGED THE REAGENT PROBES AND ADJUSTMENTS OF THE PROBE POSITIONS WERE PERFORMED. THE REAGENT PROBE AND REAGENT PROBE COVERS HAD SOME WHITE POWDER IN THE HEAD WHICH WAS CLEANED. IT WAS CONFIRMED THERE WAS NO DAMAGE. THE GEAR PUMP PRESSURE WAS SLIGHTLY TOO LOW AND WAS ADJUSTED. THE CUSTOMER MONITORED RESULTS AND HAD NOT REPORTED ANY FURTHER ISSUES SINCE THE FIELD SERVICE ENGINEER'S VISIT. THE INVESTIGATION DETERMINED THAT THE PERFORMED ACTIONS BY THE FIELD SERVICE ENGINEER SOLVED THE ISSUE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF QUESTIONABLE MAGNESIUM RESULTS FOR ONE (1) PATIENT SAMPLE ON A COBAS 8000 C 702 MODULE ANALYZER. THE INITIAL RESULT WAS 0.91 MMOL/L (ON LINE 2) AND THE REPEAT RESULT WAS 1.41 MMOL/L (ON LINE. THE SAMPLE WAS THEN REPEATED ON LINE ONE (1) WITH THE RESULTS OF 1.63 MMOL/L, 0.84 MMOL/L AND 0.84 MMOL/L. A QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE RESULT OF 0.84 MMOL/L WAS BELIEVED TO BE CORRECT. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE ASKED FOR BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629407 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR