BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® FREE T3

    MDR report key: 3477117 · Received November 19, 2013

    Report

    Report Number
    2122870-2013-00992
    Event Type
    Malfunction
    Date Received
    November 19, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 22, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS FREE T3 DEVICE WAS RETURNED FOR EVALUATION. A DEFINITIVE CAUSE OF THE INCIDENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED FREE TRIIODOTHYRONINE (FT3) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS FREE T3 ASSAY USED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM . PRIOR TO THE EVENT, AN INITIAL RESULT 2.28 PG/ML WAS OBTAINED, WHICH WAS BELOW THE NORMAL REFERENCE RANGE. THE CUSTOMER ROUTINELY RETESTS SAMPLES OUTSIDE THE NORMAL REFERENCE RANGE. THE PATIENT¿S SAMPLE WAS RETESTED ON THE SAME INSTRUMENT AND RECOVERED A VALUE OF >30 PG/ML AND FLAGGED OVR (OVER RANGE HIGH), INDICATING THE CALCULATED CONCENTRATION WAS ABOVE THE HIGHEST OR MOST CONCENTRATED CALIBRATOR. THE CUSTOMER RETESTED THE SAMPLE TWO TIMES, ON THE SAME INSTRUMENT, BOTH RECOVERED VALUES OF >30 PG/ML AND FLAGGED OVR. THE CUSTOMER NOTED ALL THREE OVR FLAGGED RESULTS WERE FROM THE SAME REAGENT PACK. THE CUSTOMER REMOVED THE REAGENT PACK FOR INSPECTION AND STATED THE REAGENT PACK APPEARED NORMAL; IT WAS NOT EMPTY, LEAKING OR DAMAGED WITH 47 TESTS REMAINED IN THE PACK. THE CUSTOMER NOTED THE REAGENT PACK WAS IN THE CORRECT POSITION, ON THE INSTRUMENT. REAGENT PACK SHARING WAS RULED OUT AS THE CUSTOMER ONLY HAS ONE INSTRUMENT IN LABORATORY. THE CUSTOMER LOADED A NEW FREE T3 REAGENT PACK AND RETESTED THE SAMPLE, WHICH RECOVERED A RESULT OF 1.97 PG/ML. DATA PROVIDED BY THE CUSTOMER SHOW THE RELATIVE LIGHT UNIT (RLU) VALUES FOR THE THREE OVR FLAGGED RESULTS ARE ALL VERY LOW AND NEAR SUBSTRATE BLANK, INDICATING INSUFFICIENT REAGENT VOLUME OR INCORRECT REAGENT WAS PIPETTED TO THE REACTION VESSEL. SINCE FREE T3 IS A COMPETITIVE ASSAY, THE LOW RLU VALUES RESULTED IN A HIGH (OVR-FLAGGED) DOSE RESULT. THERE WERE NO SAMPLE QUALITY ISSUES. OTHER TESTS FROM THE SAME SAMPLE RECOVERED ACCEPTABLE AND REPRODUCIBLE RESULTS, INDICATING THE ISSUE IS LIKELY NOT WITH THE SAMPLE. THE CUSTOMER STATED THE OVR FLAGGED RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER DISCARDED THE REAGENT PACK IN QUESTION. SERVICE WAS DECLINED AND THE INSTRUMENT WAS IN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600299 ACCESS® FREE T3 RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP BECKMAN COULTER NA 270210

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR