BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2220584 · Received August 23, 2011

    Report

    Report Number
    1823260-2011-04499
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 8, 2011
    Report Date
    January 5, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE FALSE LOW VALUE COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ONGOING ISSUE WITH QUESTIONABLE TSH RESULTS FOR 3-4 PATIENT SAMPLES FOR THE PAST FEW WEEKS. HE STATED HIS CLIENTS HAVE BEEN COMPLAINING OF LOW TSH RESULTS THAT THEY FEEL ARE FALSELY LOW. DATA WAS PROVIDED FOR ONE PATIENT SAMPLE WITH QUESTIONABLE TSH AND T3 RESULTS THAT OCCURRED ON (B)(6) 2011. THE ORIGINAL TSH RESULT WAS 0.052 UIU/ML WITH A DATA FLAG. THE REPEAT RESULT FROM THE ORIGINAL TUBE WAS 4.070 UIU/ML AND THE REPEAT RESULT FROM A POUR-OFF TUBE WAS 4.410 UIU/ML. THE ORIGINAL T3 RESULT WAS 65 NG/ML WITH A DATA FLAG. THE REPEAT RESULT FROM THE ORIGINAL TUBE WAS 126 NG/ML AND THE REPEAT RESULT FROM A POUR- OFF TUBE WAS 134.7 NG/ML. ALL OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE TSH RESULT WAS CORRECTED TO 4.070 UIU/ML AND THE T3 RESULT WAS CORRECTED TO 126 NG/ML. THE ORDERING PHYSICIAN WOULD NOT REPORT ANY INFORMATION ABOUT THE PATIENT'S CONDITION AND DID NOT STATE ANY ADVERSE EVENT HAD OCCURRED. THE TSH AND T3 REAGENT LOT NUMBERS WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE WITH THE ANALYZER DURING DIAGNOSTIC TESTING. HE CHECKED THE SAMPLE LIQUID LEVEL DETECTION VOLTAGE, SIPPER VOLTAGE, PRESSURE SENSOR VOLTAGE, AND ANALYZER VOLTAGES WITH ALL RESULTS WITHIN SPECIFICATIONS. HE CHECKED THE BEAD MIXING ASSEMBLY AND ADJUSTMENTS, SAMPLING ASSEMBLY AND ADJUSTMENTS. ALL WERE ACCEPTABLE AND WITHIN SPECIFICATIONS. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTING. HE OBSERVED THE ANALYZER AND ITS FUNCTIONS WERE PERFORMING CORRECTLY AND PER SPECIFICATION. ALL SYSTEM CHECKS WERE SUCCESSFUL. THE USER RAN QUALITY CONTROL WITH ACCEPTABLE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR