BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1935985 · Received December 22, 2010

    Report

    Report Number
    1823260-2010-07630
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER RECEIVED QUESTIONABLE FREE THYROXINE (FREE T4) RESULTS FOR FIVE PATIENT SAMPLES. ALL RESULTS ARE IN NG/DL. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED QUESTIONING THE RESULTS AND ASKED FOR REPEAT TESTING. TWO OF THE PATIENTS REQUESTED REPEAT TESTING FOR NO CHARGE, AND ONE PATIENT HAD AN APPOINTMENT SCHEDULED FOR FURTHER ENDOCRINE TESTING, BUT THAT APPOINTMENT WAS CANCELLED AFTER THE REPEAT RESULT WAS REPORTED. THE PATIENTS WERE NOT ADVERSELY AFFECTED. PATIENT SAMPLE 1 INITIAL RESULT WAS 2.01 AND THE REPEAT RESULT REPORTED ON (B)(6) 2010 WAS 1.24. PATIENT SAMPLE 2 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 2.88 AND THE REPEAT RESULT REPORTED ON (B)(6) 2010 WAS 1.16. PATIENT SAMPLE 3 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 5.09 AND THE REPEAT RESULT REPORTED ON (B)(6) 2010 WAS 1.19. PATIENT SAMPLE 4 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 2.03 AND THE REPEAT RESULT REPORTED ON (B)(6) 2010 WAS 1.33. PATIENT SAMPLE 5 WAS FROM A (B)(6) FEMALE. THE INITIAL RESULT WAS 2.89 AND THE REPEAT RESULT REPORTED ON (B)(6) 2010 WAS 1.34. THE LOT NUMBER OF THE FREE T4 REAGENT WAS 15815503. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE REAGENT MIXING PADDLE WAS DAMAGED AND THERE WAS A MEASUREMENT SYSTEM ELECTRONIC FAILURE. HE REPLACED THE REAGENT MIXING PADDLE AND REPLACED THE MEASURING CELLS. TO VERIFY THE ANALYZER OPERATION, HE RAN SUCCESSFUL PERFORMANCE TESTING, CALIBRATION AND QUALITY CONTROL. THE FIELD APPLICATION SPECIALIST DETERMINED THERE WERE FOAM AND/OR BUBBLES IN THE MICRO-PARTICLE REAGENT THAT WERE CAUSED BY THE DAMAGED MIXING PADDLE. SHE CONCLUDED THE FOAM OR BUBBLES IN THE MICRO-PARTICLE REAGENT WOULD LEAD TO THE ANALYZER NOT PIPETTING THE CORRECT AMOUNT OF REAGENT THEREFORE LEADING TO INCORRECT PATIENT 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
    1 020 YR