BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3072868 · Received April 23, 2013

    Report

    Report Number
    2122870-2013-00397
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    Z-0607-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED TO REFLECT THAT THIS EVENT IS NOT ASSOCIATED WITH A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED BY THE ER STAFF IN A 5ML LITHIUM HEPARIN TUBE AND CENTRIFUGED AT 6000RPM FOR 8 MINUTES. THE SAMPLE WAS STORED AT ROOM TEMPERATURE FOR UP TO EIGHT HOURS BEFORE BEING REPEATED ON THE SAME INSTRUMENT. PER CUSTOMER, NO SAMPLE QUALITY ISSUES WERE NOTED. SYSTEM CHECKS ON (B)(6) 2013 PASSED WITHIN SPECIFICATIONS. THE CUSTOMER STATED THAT QC IS RUN EVERY TWENTY FOUR HOURS AT THE BEGINNING OF THE DAY SHIFT. BEC CUSTOMER TECHNICAL SUPPORT (CTS) PERFORMED TROUBLESHOOTING OVER THE PHONE AND ADVISED THE CUSTOMER REGARDING PROPER REAGENT LOADING TECHNIQUE AND RUNNING QC ON EVERY REAGENT PACK, IF MULTIPLE REAGENT PACKS ARE USED. THE CAUSE OF THE EVENT MAY BE ATTRIBUTED TO USE ERROR CAUSED BY PACK MISLOADING.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT TROPONIN (ACCUTNI) RESULTS WERE BEING REPORTED AS NEGATIVE, <0.06NG/ML ON AN ACCESS 2 IMMUNOASSAY SYSTEM. PER CUSTOMER, THEY HAD A MISLOADED AN ACCUTNI I REAGENT PACK AND THE PACK WAS NOT PRESENT IN THE DESIGNATED POSITION WHILE RUNNING QC. THE CUSTOMER FOUND THE MISLOADED REAGENT PACK AND DISCARDED IT. QC WAS THEN REPEATED AND WAS WITHIN EXPECTED RANGES. ONE PATIENT RESULT WAS POSITIVE UPON REPEAT. THE PATIENT HAD BEEN DISCHARGED BASED ON NEGATIVE ACCUTNI RESULT AND SO THERE WAS A DELAY IN TREATMENT FOR AN ELEVATED RESULT. THE PATIENT WAS CALLED BACK TO THE HOSPITAL AND TREATED. THE EXACT NATURE OF THE TREATMENT WAS NOT PROVIDED BY THE CUSTOMER. THE ERRONEOUS PATIENT RESULT WAS GENERATED USING ACCUTNI REAGENT LOT 224073.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175014 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other