BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 20281004 · Received September 23, 2024

    Report

    Report Number
    1823260-2024-02742
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 29, 2024
    Report Date
    October 29, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MDR, THE SECOND TO FIFTH LINE SHOULD HAVE BEEN: "THE INITIAL RESULT USING THE ASSAY'S URINE PARAMETER IS 1.16 MMOL/L. THE FIRST REPEAT RESULT USING THE ASSAY'S URINE PARAMETER IS 66.08 MMOL/L. THE SECOND RESULT USING THE ASSAY'S SERUM PARAMETER IS 66.76 MMOL/L. THE THIRD REPEAT RESULT USING 'DECREASE MODE' WAS 71.26 MMOL/L." INSTEAD OF: "THE INITIAL RESULT USING THE ASSAY'S URINE PARAMETER IS 1.16 MMOL/L. THE REPEAT RESULT USING THE ASSAY'S URINE PARAMETER IS 66.08 MMOL/L. THE REPORTER ALSO SUBMITTED A REPEAT RESULT OF 71.26 MMOL/L. THE REPEAT RESULT USING THE ASSAY'S BLOOD PARAMETER IS 66.76 MMOL/L." THE INVESTIGATION REVIEWED THE REACTION KINETICS AND NOTED THAT NO PATIENT SAMPLE WAS PIPETTED AND TRANSFERRED TO THE CUVETTE. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE (INCORRECT PATIENT SAMPLE TUBE SIZE) AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 8000 C702 MODULE IS (B)(6). THE INVESTIGATION REVIEWED THE INITIAL RESULT'S REACTION KINETICS. THE REACTION KINETICS SHOWED THAT NO PATIENT SAMPLE WAS PIPETTED AND TRANSFERRED TO THE CUVETTE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE UREA/BUN (UREAL) ASSAY RESULT FROM ONE URINE PATIENT SAMPLE TESTED ON THE COBAS 8000 C702 MODULE. THE INITIAL RESULT USING THE ASSAY'S URINE PARAMETER IS 1.16 MMOL/L. THE REPEAT RESULT USING THE ASSAY'S URINE PARAMETER IS 66.08 MMOL/L. THE REPORTER ALSO SUBMITTED A REPEAT RESULT OF 71.26 MMOL/L. THE REPEAT RESULT USING THE ASSAY'S BLOOD PARAMETER IS 66.76 MMOL/L. THE REPORTER STATED THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS ALERTING THEM TO AN ISSUE WITH THE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430726 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS 775888

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male