BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 3132722 · Received May 29, 2013

    Report

    Report Number
    2122870-2013-00481
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THE FIRST PERISTALTIC PUMP TUBING CLOGGED AND FLUID IN THE REACTION VESSEL (RV). THE FSE ALSO OBSERVED THE ASPIRATE PROBE #2 PERISTALTIC PUMP TUBING WAS OBSTRUCTED. THE OBSTRUCTION PREVENTED THE ASPIRATE PROBE FROM COMPLETELY CLEANING THE REACTION VESSEL, WHICH CAUSED THE ELEVATED RESULTS. THE FSE REPLACED THE WASH/READ CAROUSEL SIDE BEARINGS, ALL ASPIRATE PROBES, ASPIRATE PROBE PERISTALTIC TUBING, THE SAMPLE PIPETTOR TIP, SUBSTRATE PROBE, INCUBATOR BELT, AND ALL VESSEL HOLDERS. THE FSE RE-INSTALLED THE ANALYTICAL MODULE AND PERFORMED INCUBATOR BELT CALIBRATION, INCUBATOR BELT ALIGNMENTS, PERFORMED 4 CYCLES OF INCUBATOR TRACK, AND VESSEL HOLDER AND WASH CAROUSEL TRANSFER EXERCISERS. THE FSE VERIFIED SAMPLE PIPETTOR ULTRASONICS TRANSDUCER VOLTAGES, SAMPLE PIPETTOR TRANSDUCER TEMPERATURE, PERFORMED ALL SAMPLE PIPETTOR ALIGNMENTS, AND PRIMED THE FLUIDICS MANIFOLD. THE FSE VERIFIED ALL ASPIRATE PROBES WERE FUNCTIONING PROPERLY. THE FSE PERFORMED COMPLETE SYSTEM CHECK AND RESULTS PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. THE FSE PERFORMED HSINC52 AND HSWSON SERVICE ASSAY TEST; RESULTS PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 2122870-2013-00481, 2122870-2013-00482, 2122870-2013-00483.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NON-REPRODUCIBLE, ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION, FOR THREE PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM UTILIZED IN CONJUNCTION WITH THE ACCESS ACCUTNI REAGENT AND CALIBRATOR. SUBSEQUENT ANALYSIS OF THE PATIENTS¿ SAMPLES, ON AN ALTERNATE INSTRUMENT, RECOVERED LOWER TROPONIN I RESULTS WITHIN THE NORMAL REFERENCE RANGE. ALL THREE ELEVATED PATIENT RESULTS WERE RELEASED OUT OF THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT FOR THIS REPORTED PATIENT. PATIENT SAMPLES ARE COLLECTED IN 13X75 MM HEPARINIZED PLASTIC SEPARATION TUBES (PST) BY THE LABORATORY OR EMERGENCY ROOM (ER) PERSONNEL AND CENTRIFUGED IN A STATSPIN CENTRIFUGE FOR THREE MINUTES, AT ROOM TEMPERATURE. THREE LEVELS OF QUALITY CONTROL (QC) HAD BEEN IN RANGE FOR THE WEEK PRIOR TO AND ON THE DAY OF THE EVENT. THE CUSTOMER VERIFIED THE SUBSTRATE PROBE AND BOTTLE FITTINGS, AND ASPIRATED AND DISPENSED THE PROBE SEATING AND TUBING CONNECTIONS. THE SYSTEM CHECK FAILED THE WASH PORTION WITH A WASHED RELATIVE LIGHT UNIT (RLU) MEAN OF 208,773 AND A WASHED PERCENT COEFFICIENT OF VARIATION (%CV) OF 12.53%. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THIS IS REPORT ONE OF THREE REFERENCING PATIENT NUMBER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234895 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1