BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 10238853 · Received July 7, 2020

    Report

    Report Number
    1823260-2020-01609
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 13, 2020
    Report Date
    July 7, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER CHECKED BOTH ANALYZERS. GEAR PUMP PRESSURES AND PROBE ALIGNMENTS WERE CHECKED. THE ISSUE WAS SUSPECTED TO BE RELATED TO THE REAGENT. A NEW BUN REAGENT LOT WAS LOADED AND THE ISSUE WAS RESOLVED. ON C 501 SERIAL NUMBER (B)(4), THE FIELD SERVICE ENGINEER FOUND A MISADJUSTED SYRINGE LOCKING SCREW. THE SCREW WAS ADJUSTED. CELL RINSE VOLUMES WERE ADJUSTED. PRECISION STUDIES WERE PERFORMED AND MET SPECIFICATIONS. THE CUSTOMER RAN CALIBRATION AND CONTROLS; RESULTS MET THE CUSTOMER'S SPECIFICATIONS. THE LAST CALIBRATION PERFORMED ON (B)(6) 2020 FOR C 501 SERIAL NUMBER (B)(4) WAS OK. QUALITY CONTROLS WERE WITHIN RANGE ON THIS ANALYZER, SHOWING NO INDICATION OF A REAGENT PERFORMANCE ISSUE. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE FOR ANALYZER SERIAL NUMBER (B)(4). FOR ANALYZER SERIAL NUMBER (B)(4), THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT ON THIS ANALYZER COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH UREAL UREA/BUN ON TWO COBAS 6000 C (501) MODULE ANALYZERS. THE REPORTER STATED THAT THE BUN CALIBRATION IS DRIFTING, AS THE CONTROLS WERE GOING OUTSIDE OF RANGE. THE REPORTER NOTED THAT A NEW LAMP WAS INSTALLED ON C501 SERIAL NUMBER (B)(4) ON (B)(6) 2020 AND THE LAMP READING WAS UNUSUALLY LOW. THE SAMPLE INITIALLY RESULTED WITH A BUN VALUE OF 81 MG/DL ACCOMPANIED BY A DATA FLAG WHEN TESTED ON C501 ANALYZER SERIAL NUMBER (B)(4). THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A DOCTOR. THE SAMPLE WAS REPEATED ON C 501 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A BUN VALUE OF 80 MG/DL. THE ASSAY WAS RE-CALIBRATED AND REPEATED ON C 501 ANALYZER SERIAL NUMBER (B)(4), RESULTING WITH A VALUE OF 28 MG/DL ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701900 UREA/BUN UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN CDQ ROCHE DIAGNOSTICS NA 46026801

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR