BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALBUMIN GEN.2

    MDR report key: 2171733 · Received July 22, 2011

    Report

    Report Number
    1823260-2011-03897
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 28, 2011
    Report Date
    November 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIX
    PMA / PMN Number
    K033009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE EVENT COULD NOT CLEARLY IDENTIFY A SPECIFIC ROOT CAUSE AS THE CUSTOMER REFUSED TO PROVIDE FURTHER DATA FOR THE ADDITIONAL EVALUATION. THE PROBLEM WAS SOLVED BY THE APPROPRIATE TROUBLESHOOTING PROCESS WHERE IT WAS FOUND THERE WAS A DILUTION OF THE REACTION BY A LEAKING R2 NOZZLE, AV2 VALVE BLOCK AND R2 NOZZLE. THESE PARTS WERE REPLACED DURING THE SERVICE VISIT. AS FAR AS IT WAS KNOWN, NO PATIENTS WERE ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR MULTIPLE ASSAYS FOR APPROXIMATELY 15 PATIENTS WHEN TESTED ON A COBAS 6000 C501 MODULE, SERIAL NUMBER (B)(4). THE ASSAYS INCLUDED ALBUMIN (GENERATION 2), CREATININE KINASE, CREATININE (JAFFE GENERATION 2), ALKALINE PHOSPHATASE, HDL-CHOLESTEROL AND MAGNESIUM. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND THE CUSTOMER SENT APPROXIMATELY 39 CORRECTED REPORTS. THE CUSTOMER RECEIVED HIGH ALBUMIN RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES. THE CUSTOMER PROVIDED ONE EXAMPLE WHICH INITIALLY RECOVERED AROUND 5.8 G/DL AND WHEN REPEATED ON ANOTHER COBAS 6000 C501 ANALYZER GENERATED 4.2 G/DL. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THE DISCREPANCIES. THE FIELD SERVICE REPRESENTATIVE DETERMINED A DEFECTIVE VALVE ON THE VALVE BANK AV2 WAS THE CAUSE AND HE REPLACED THE VALVE BANK AV2. THE FIELD SERVICE REPRESENTATIVE TESTED THE REPLACEMENT VALVE AND VERIFIED THE INSTRUMENT WAS OPERATING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALBUMIN GEN.2 BROMCRESOL GREEN DYE-BINDING, ALBUMIN CIX ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1