BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 10238855 · Received July 7, 2020

    Report

    Report Number
    1823260-2020-01608
    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 COULD NOT DETERMINE A CAUSE. THE GEAR PUMP PRESSURE AND RINSE MECHANISM FUNCTION WERE INSPECTED. THE SYSTEM REAGENT, RINSE, AND CELL BLANK VOLUMES WERE CONFIRMED. THE VACUUM FUNCTION WAS CONFIRMED. CALIBRATION SIGNALS WERE FOUND TO BE IRREGULAR. REAGENT FROM A SISTER SITE WAS USED AND THE IRREGULAR CALIBRATION SIGNAL PROBLEM PERSISTED. PRECISION STUDIES WERE PERFORMED. BUN PRECISION WAS POOR, BUT PRECISION ON ALL OTHER ASSAYS RECOVERED WITHIN GUIDELINES. THE REPORTER NOTED THAT THE LABORATORY DEIONIZED WATER POLISHING TANKS WERE REPLACED 3-4 DAYS PRIOR TO THE ISSUE. THE SYSTEM WAS DECONTAMINATED. A REPEAT OF CALIBRATION AND CONTROLS SHOWED NO IMPROVEMENT. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH UREAL UREA/BUN ON A COBAS 6000 C (501) MODULE. INCORRECT VALUES FROM THESE SAMPLES WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY A DOCTOR. THE REPORTER STATED THAT THE BUN CALIBRATION IS DRIFTING, AS THE CONTROLS WERE GOING OUTSIDE OF RANGE. THE FIRST PATIENT SAMPLE INITIALLY RESULTED WITH A BUN VALUE OF 97 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE REPEATED AS 49 MG/DL ON (B)(6) 2020. THE SECOND PATIENT SAMPLE, FROM A (B)(6) FEMALE PATIENT BORN ON (B)(6) 1946, INITIALLY RESULTED WITH A BUN VALUE OF 82 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE REPEATED AS 27 MG/DL ON (B)(6) 2020. THE THIRD PATIENT SAMPLE, FROM A (B)(6) FEMALE PATIENT BORN ON (B)(6) 1935, INITIALLY RESULTED WITH A BUN VALUE OF 105 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE REPEATED AS 34 MG/DL ON (B)(6) 2020. THE FOURTH PATIENT SAMPLE, FROM A (B)(6) FEMALE PATIENT BORN ON (B)(6) 1958, INITIALLY RESULTED WITH A BUN VALUE OF > 137 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED AT A DECREASED SAMPLE VOLUME, RESULTING WITH A VALUE OF 294 MG/DL ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS THEN REPEATED A SECOND TIME ON (B)(6) 2020, RESULTING WITH A VALUE OF 86 MG/DL, WHICH WAS BELIEVED TO BE CORRECT. THE C 501 ANALYZER SERIAL NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701901 UREA/BUN UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN CDQ ROCHE DIAGNOSTICS NA 46026801

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR