BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 501 MODULE

    MDR report key: 13893129 · Received March 24, 2022

    Report

    Report Number
    1823260-2022-00853
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 2, 2022
    Report Date
    July 25, 2022
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) REPLACED THE GEAR PUMP HEAD (GPH), CHOKE AND BOTH OF THE REAGENT PROBES. HE SET UP THE GPH PRESSURE AND PROBE POSITIONS. HE CHECKED THE WATER LEVELS AND DETERGENTS. HE STARTED THE ANALYZER ON A MECHANICAL CHECK AND NOTED REAGENT PROBE ERRORS. HE REPLACED THE UPPER POSITION SENSOR AND PERFORMED A MECHANICAL CHECK WITH NO FURTHER ISSUES. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    SAMPLE 22L412414 HAD AN INITIAL RESULT FROM THE ANALYZER AT 9:28 OF 0.36 MMOL/L WITH A REPEAT RESULT FROM THEIR OTHER ANALYZER AT 9:43 OF 2.45 MMOL/L. SAMPLE 22L412450 HAD AN INITIAL RESULT FROM THE ANALYZER AT 9:37 OF 0.39 MMOL/L WITH A REPEAT RESULT FROM THEIR OTHER ANALYZER AT 10:14 OF 2.19 MMOL/L. SAMPLE 22L412655 HAD AN INITIAL RESULT FROM THE ANALYZER AT 9:47 OF 0.42 MMOL/L WITH A REPEAT RESULT FROM THEIR OTHER ANALYZER AT 10:14 OF 1.91 MMOL/L. SAMPLE 22L411436 HAD AN INITIAL RESULT FROM THE ANALYZER AT 9:56 OF 0.37 MMOL/L WITH A REPEAT RESULT FROM THEIR OTHER ANALYZER AT 10:19 OF 2.34 MMOL/L.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION EXCLUDED REAGENT ISSUES. THE ASSAY AND MODULE WERE CONFIRMED TO BE PERFORMING WITHIN SPECIFICATIONS. AFTER SERVICE, NO FURTHER ISSUES WERE REPORTED BY THE CUSTOMER.  THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A MAINTENANCE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA CALCIUM RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENTS TESTED ON A COBAS 6000 C501 MODULE. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPORTER WAS ABLE TO PROVIDE 2 EXAMPLES OF QUESTIONABLE RESULTS: SAMPLE 22L361002 HAD AN INITIAL RESULT AT 2:43 PM OF 0.45 MMOL/L. THE REPEAT RESULT AT 3:39 WAS 2.55 MMOL/L. SAMPLE 22L359577 HAD AN INITIAL RESULT AT 2:55 PM OF 0.45 MMOL/L WITH A REPEAT RESULT OF 2.34 MMOL/L. THE REAGENT LOT NUMBER IS 586586. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367636 COBAS C 501 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown