BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 12057849 · Received June 24, 2021

    Report

    Report Number
    1823260-2021-01815
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 30, 2021
    Report Date
    August 12, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ON 23-JUN-2021, THE FIELD SERVICE ENGINEER CLEANED THE REAGENT AND SAMPLE LINES, REPLACED THE SEAL PIECES IN SYRINGES, AND CHECKED THE LAUNDRY TUBING AND PUMP PRESSURE WHICH WERE ALL OKAY. ON 02-JUL-2021, THE FIELD SERVICE ENGINEER PERFORMED CHECKS, REPLACED THE REAGENT PROBE, AND RAN PRECISION TESTING. A SPECIAL WASH CYCLE WAS IDENTIFIED AS MISSING AND WAS ADDED. THE CUSTOMER HAS REPORTED NO ADDITIONAL DISCREPANCIES. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER PERFORMED A FULL DECONTAMINATION OF THE SYSTEM AND CLEANED THE BLACK TANK, DEGASSER, AND TUBING. THE CALIBRATION AND QC WERE IN RANGE. 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 QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR THREE PATIENTS WITH THE COBAS 6000 C 501 MODULE. PATIENT 1: THE INITIAL RESULT AT 14:04 WAS 1.93 MMOL/L. THE REPEATED RESULT AT 14:34 WAS 3.48 MMOL/L. THE SECOND REPEATED RESULT AT 15:01 WAS 1.96 MMOL/L. PATIENT 2: THE INITIAL RESULT WAS 2.41 MMOL/L. THE REPEATED RESULT WAS 3.45 MMOL/L. PATIENT 3: THE INITIAL RESULT WAS 2.19 MMOL/L. THE REPEATED RESULT WAS 3.X MMOL/L (THE DIGITS AFTER THE DECIMAL POINT WERE NOT PROVIDED). IT IS UNKNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER WAS 518592 WITH AN EXPIRATION DATE OF 28-FEB-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959853 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1