BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2874559 · Received December 15, 2012

    Report

    Report Number
    2122870-2012-01990
    Event Type
    Injury
    Date Received
    December 15, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 17, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED AIR POCKETS IN THE DISPENSE PROBE AND RESEATED THE WASH AND PRECISION PUMP VALVES AND GASKETS. THE FSE REPLACED THE MANIFOLD O-RINGS IN RESPONSE TO THE AIR POCKETS. THE FSE ALSO REPLACED THE VACUUM PUMP AS IT WAS NOT HOLDING VACUUM. THE FSE PERFORMED MIXER PULLEY MODIFICATION, ADJUSTED THE MIXER SPEED TO BE WITHIN INSTRUMENT SPECIFICATIONS, CLEANED THE ANALYTICAL MODULE DUE TO WASH BUFFER BUILD-UP, VERIFIED ALIGNMENTS AND ULTRASONICS VOLTAGES, PRIMED THE SYSTEM, AND PERFORMED SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK. THE FSE PERFORMED TROPONIN CALIBRATION AND COMPLETED A 15-REPETITION PRECISION TEST UTILIZING LOW LEVEL QUALITY CONTROL (QC) MATERIAL. ALL RESULTS WERE WITHIN SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE CUSTOMER STATED PATIENT SAMPLES WERE COLLECTED INTO LITHIUM HEPARIN PLASMA TUBES AND CENTRIFUGED AT 5,000 RPM (ROTATIONS PER MINUTE) FOR FIVE MINUTES IN THE PRIMARY PLASMA TUBE. THE PLASMA SAMPLE IS THEN ALIQUOTTED INTO AN ALTERNATE TUBE AND CENTRIFUGED AT 3,000 RPM FOR THREE MINUTES IN A STAT SPIN CENTRIFUGE. THE CUSTOMER STATED QUALITY CONTROL (QC) WAS WITHIN RANGE PRIOR TO AND AFTER THE ELEVATED RESULTS WERE OBTAINED. THE CUSTOMER INDICATED SYSTEM CHECK, PERFORMED ON (B)(6) 2012, PASSED WITHIN SPECIFICATION. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2012-01988, 2122870-2012-01989, 2122870-2012-01990, 2122870-2012-01991, 2122870-2012-01992, 2122870-2012-01993, 2122870-2012-01994, 2122870-2012-01995, 2122870-2012-01996, 2122870-2012-01997.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED TROPONIN I (ACCESS ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, FOR TEN PATIENTS, INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED BY THE EMERGENCY ROOM (ER) PHYSICIANS. ALL TEN PATIENTS WERE ADMITTED TO THE HOSPITAL DUE TO THE ERRONEOUS RESULTS. THREE OF THE PATIENTS WERE GIVEN NITROGLYCERIN BASED ON THE ERRONEOUS RESULTS. SUBSEQUENT TESTING OF ALL THE PATIENT SAMPLES, ON AN ALTERNATE METHODOLOGY, RECOVERED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. AMENDED REPORTS WERE ISSUED FOR ALL THE IMPACTED PATIENTS. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THIS REPORT REFERENCES PATIENT (B)(6). BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization