BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 2185815 · Received August 1, 2011

    Report

    Report Number
    1823260-2011-04114
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    July 19, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    PMA / PMN Number
    K972250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. IT WAS NOTED THE ISSUE HAS NOT REOCCURRED SINCE THE USER BEGAN DISCARDING THE CUPS AND STOPPED REUSING EMPTY CUPS. GOOD LABORATORY PRACTICE IS ESSENTIAL TO THE GENERATION OF PLAUSIBLE PATIENT RESULTS. NONE OF THE PATIENTS WAS ADVERSELY AFFECTED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    OTHER ASSAYS RELATED TO THIS EVENT ARE REPORTED IN MEDWATCH REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES THAT HAD BEEN ALIQUOTED BY THE MPA (MODULAR PREANALYTIC ANALYZER) THEN TESTED ON THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4). DATA WAS PROVIDED FOR ONE PATIENT SAMPLE WHOSE RESULTS WERE DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL BUN RESULT WAS 66 MG/DL AND THE REPEAT RESULT FROM THE PRIMARY TUBE WAS 6 MG/DL. THE PATIENT WAS NOT ADMITTED TO A MEDICAL FACILITY; TREATMENT WAS NOT PROVIDED, ALTERED OR WITHHELD DUE TO THE ERRONEOUS RESULTS THAT WERE REPORTED OUT. THE USER DECLINED A SERVICE VISIT AND STATED SHE WOULD MONITOR THE SITUATION. THE USER STATED THEY WERE TOLD NOT TO REUSE THE EMPTY CUPS LEFT IN THE RACKS AFTER PROCESSING BY THE MPA, BUT THEY DECIDED TO CHECK THE CUPS AND IF THEY LOOKED EMPTY, THEN THEY WOULD REUSE THE CUPS. THEY HAVE DISCONTINUED REUSING EMPTY CUPS THAT WERE LEFT IN THE RACKS AND HAVE NOT EXPERIENCED A REOCCURRENCE OF THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1