BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2781246 · Received October 10, 2012

    Report

    Report Number
    1823260-2012-05071
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 25, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THE ISSUE WAS NOT REPRODUCIBLE. THE DATA PROVIDED BY THE CUSTOMER WAS EVALUATED. CALIBRATION AND QUALITY CONTROL DATA WERE REVIEWED. THERE IS NO EVIDENCE OF ANY ISSUE WITH THE REAGENT CALIBRATION OR SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE RESULTS ON TOTAL (FREE + COMPLEXED) PROSTATE-SPECIFIC ANTIGEN (TPSA) FOR ONE PATIENT SAMPLE. ALL RESULTS ARE IN NG/ML. THE ORIGINAL RESULT, RUN ON (B)(6) 2012 WAS 0.028, WHICH WAS CONVERTED TO <0.1 BY THE CUSTOMER'S LIS. THE <0.1 RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, AND WAS QUESTIONED BY THE PHYSICIAN. THE REPEAT RESULT WAS GENERATED ON ANALYTICAL E MODULE SERIAL NUMBER (B)(4) WAS 6.77. A CORRECTED REPORT WITH A VALUE OF 6.8 WAS SENT TO THE FLOOR AND TO THE PHYSICIAN. THE ORIGINAL TUBE WAS REPEATED ON ANOTHER ANALYZER SERIAL NUMBER (B)(4) AND GENERATED A RESULT OF 6.74. THE ORIGINAL TUBE WAS THEN POURED OVER INTO AN ALIQUOT TUBE AND GENERATED A RESULT OF 6.93 ON ANALYZER SERIAL NUMBER (B)(4). THE REPEAT RESULTS WERE CONSIDERED TO BE THE CORRECT RESULTS. THERE WAS NO ADVERSE EVENT. THE TPSA REAGENT LOT IN USE WAS 16676201, WITH AN EXPIRATION DATE OF 05/31/2013. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE. HE REPLACED THE PINCH TUBING, MIXING PADDLE AND CHECKED THE MECHANICAL ADJUSTMENTS. HE PERFORMED PRECISION TESTING, WHICH PASSED MANUFACTURER'S SPECIFICATIONS.

    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