BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 10482438 · Received September 2, 2020

    Report

    Report Number
    1823260-2020-02170
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    July 30, 2020
    Report Date
    January 6, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DIFFERENT REAGENT LOTS AND TESTS ARE AFFECTED, THEREFORE A REAGENT ISSUE IS UNLIKELY. CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT AND FOUND IT TO BE OK, SO A GENERAL HARDWARE ISSUE IS ALSO UNLIKELY. THE REPORTER STATED THE ISSUE OCCURRED AGAIN ONE MONTH LATER AND IT WAS FOUND THAT THE URINE SAMPLE TUBE WAS FULL AND CONTAMINATED THE SERUM SAMPLE. TO PREVENT SUCH CONTAMINATION, THE CUSTOMER STATED THEY STARTED NOT SENDING COMPLETELY FULL URINE TUBES TO THE ANALYZER, BUT ALIQUOTING PART OF THESE TUBES TO USE FOR TESTING. SINCE THE CUSTOMER STARTED DOING THIS, NO FURTHER ISSUES HAVE OCCURRED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). [(B)(6)].

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH CREP2 CREATININE PLUS VER.2 AND UREAL UREA/BUN ON A COBAS 6000 C (501) MODULE. VALUES FROM THE SAMPLE WERE REPORTED OUTSIDE OF THE LABORATORY TO THE DOCTOR. THIS MEDWATCH WILL APPLY TO THE BUN ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE CREATININE ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. MEASUREMENTS WERE PERFORMED WITH A SERUM TUBE AND A PLASMA TUBE COLLECTED FROM THE PATIENT AT THE SAME TIME. THE SERIAL NUMBER OF THE C 501 ANALYZER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949411 UREA/BUN UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN CDQ ROCHE DIAGNOSTICS NA 475906

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR NO MEDICATION.