BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1002620 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01346
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    October 18, 2007
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS DISCREPANT PT RESULTS FOR MULTIPLE TESTS. THE FOLLOWING EXAMPLES WERE PROVIDED: PT 1: INITIAL FOLATE GAVE 7.43 NG/ML; REPEAT GAVE 3.31 NG/ML. PT 2: INITIAL FOLATE GAVE 9.5 NG/ML; REPEAT GAVE 5.11 NG/ML. PT 3: INITIAL FOLATE GAVE 15.65 NG/ML; REPEAT GAVE 9.73 NG/ML. PT 4: INITIAL FOLATE GAVE 5.86 NG/ML; REPEAT GAVE 301 NG/DL. PT 5: INITIAL FOLATE GAVE 20.0 NG/ML; REPEAT GAVE 11.17 NG/ML. PT 6: INITIAL FOLATE GAVE 9.96 NG/ML; REPEAT GAVE 5.74 NG/ML. PT 7: INITIAL FOLATE GAVE 9.43 NG/ML; REPEAT GAVE 6.0 NG/ML. PT 8: INITIAL PROLACTIN GAVE 254.4 UIU/ML; REPEAT GAVE 401 UIU/ML. PT 9: INITIAL FREE T4 GAVE 28.4 PMOI/L; REPEAT GAVE 16.0 PMOI/L. PT 10: INITIAL FOLATE GAVE 7.08 NG/ML; REPEAT GAVE 3.6 NG/ML. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE INVESTIGATIONAL UNIT WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE, HOWEVER NOTED SAMPLES CONTAINED ELEVATED TOTAL PROTEIN CONCENTRATIONS. THE PACKAGE INSERT DOCUMENTS ELEVATED TOTAL PROTEIN CONCENTRATIONS. THE PACKAGE INSERT DOCUMENTS ELEVATED TOTAL PROTEIN CONCENTRATIONS MAY INTERFERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS D MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK