BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® FREE T3

    MDR report key: 3178643 · Received June 19, 2013

    Report

    Report Number
    2122870-2013-00558
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 IS UNKNOWN.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED ERRONEOUS FREE TRIIODOTHYRONINE (FT3) RESULTS AND OVR (OVER RANGE) FLAGS, FOR TEN PATIENTS, INVOLVING THE ACCESS FREE T3 ASSAY UTILIZED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. ALL THE ERRONEOUS RESULTS WERE GREATER THAN 30 PG/ML, WITH OVR FLAGS. ONE PATIENT SAMPLE OBTAINED AN INITIAL RESULT OF 3.51 PG/ML. SUBSEQUENT ANALYSIS OF THE SAMPLE PRODUCED A RESULT GREATER THAN 30 PG/ML. A SECOND REANALYSIS PRODUCED A RESULT OF 3.02 PG/ML. THE CUSTOMER RETESTED ALL AFFECTED PATIENT SAMPLES WITH OVR FLAGS AND OBTAINED LOWER FREE T3 RESULTS. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER UNLOADED ALL FREE T3 REAGENT PACKS FROM THE SYSTEM AND DISCOVERED WELL #4 WAS EMPTY AND CRACKED. THE CUSTOMER STATED THERE WAS NO EVIDENCE OF A REAGENT LEAK WHEN OPENING THE REAGENT BOX AND PLACING IT ONTO THE INSTRUMENT. THE CUSTOMER STATED NONE OF THE BOXES WERE NOTICEABLY DAMAGED UPON RECEIPT OF THE PRODUCT. QUALITY CONTROL (QC) WAS PERFORMED AT THE TIME OF THE EVENT USING OTHER REAGENT PACKS THAT WERE ONBOARD THE SYSTEM. NO QC FLAGS WERE NOTED. A REPLACEMENT FREE T3 REAGENT PACK WAS SHIPPED TO THE CUSTOMER. NO OTHER ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277663 ACCESS® FREE T3 RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE CDP BECKMAN COULTER NA 227410

    Patients

    Seq Age Sex Outcome Treatment
    1