BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLESTEROL GEN.2

    MDR report key: 2133683 · Received June 20, 2011

    Report

    Report Number
    1823260-2011-03345
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHH
    PMA / PMN Number
    K031824
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE INITIAL REPORTER SENT A REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS RECEIVED: THE CHOLESTEROL RESULT FROM THE SECOND SAMPLE TESTED AT THE CLINIC WAS PROVIDED. THE RESULT WAS 5 MMOL/L.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE OF THE DISCREPANCIES WAS A PREANALYTICAL ISSUE (INCLUDING INCORRECT HANDLING OF THE SAMPLES OR WRONG STORAGE). THE INSTRUMENT AND ASSAY PERFORMED ACCORDING TO SPECIFICATIONS AS DEMONSTRATED BY THE GOOD QUALITY CONTROL, CALIBRATION AND PRECISION. THERE ALSO WERE NO OTHER ASSAY OUTLIERS. SINGLE FALSE HIGH CHOLESTEROL RESULTS MAY RESULT IN UNNECESSARY FURTHER TESTS. THE ONLY IMPACT TO THIS PATIENT WAS AN ADDITIONAL SAMPLE DRAW FOR TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CHOLESTEROL RESULTS FOR ONE PATIENT WHEN TESTED ON A COBAS INTEGRA 400+ ANALYZER, (B)(4). THE INITIAL RESULT WAS 10.67 MMOL/L AND WAS REPORTED TO THE PATIENT. ON (B)(6) 2011, THE SAME SAMPLE WAS REPEATED AND RECOVERED 5.43 MMOL/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY ON (B)(6) 2011 AS THE CORRECT RESULT. THE PATIENT VISITED ANOTHER CLINIC TO CHECK THE RESULT AND BLOOD WAS COLLECTED A SECOND TIME. THE CHOLESTEROL RESULT FROM THIS SAMPLE WAS NOT PROVIDED. NO ADVERSE EVENTS WERE REPORTED. THE PATIENT'S CONDITION IS "NORMAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOLESTEROL GEN.2 ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL CHH ROCHE DIAGNOSTICS NA 639312-01

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR