BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 4911588 · Received July 14, 2015

    Report

    Report Number
    2122870-2015-00420
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 27, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE PATIENT DEMOGRAPHIC OF ONE (1) (B)(6) PATIENT; HOWEVER, IT IS UNKNOWN IF THIS IS THE PATIENT WHO EXPERIENCED THE ADVERSE EVENT. PATIENT DEMOGRAPHICS OF DATE OF BIRTH, SEX AND WEIGHT WERE NOT PROVIDED BY THE CUSTOMER. PATIENT DEMOGRAPHICS OF AGE, DATE OF BIRTH, SEX AND WEIGHT WERE NOT PROVIDED BY THE CUSTOMER FOR THE REMAINING PATIENTS. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS INSTRUMENT PERFORMANCE. WHILE ON SITE, THE FSE VERIFIED INSTRUMENT ALIGNMENTS, TEMPERATURES AND ULTRASONICS OPERATION AND NOTED NO ISSUES. THE FSE DID NOTE A LARGE AMOUNT OF BUBBLES AND FOAM IN THE WASH PUMP CHAMBER DURING A PRIME. THE FSE THEN REPLACED THE ROTOR AND STATOR DUE TO A POOR FIT BETWEEN THE SHAFT AND THE ROTOR HEAD. AFTER THE REPAIRS WERE COMPLETED, ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THE ELEVATED ACCESS ACCUTNI+3 RESULTS WAS DUE TO A HARDWARE MALFUNCTION OF THE WASHING SYSTEM. ALL MDRS ASSOCIATED WITH THIS REPORT: 2122870-2015-00420; 2122870-2015-00421; 2122870-2015-00422.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ISSUES WITH ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS INVOLVING THE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) FOR AN UNKNOWN NUMBER OF PATIENTS. ATTEMPTS WERE MADE TO CLARIFY THE CUSTOMER PROVIDED INFORMATION; HOWEVER, AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL INFORMATION SPECIFIC TO THE DATE OF THE EVENT, THE NUMBER OF PATIENTS INVOLVED, THE SPECIFIC ACCESS ACCUTNI+3 RESULTS OF THE PATIENTS INVOLVED AND THE PATIENTS TO WHICH A CHANGE OR IMPACT TO PATIENT TREATMENT OCCURRED. AT LEAST TWO (2) ELEVATED RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. INFORMATION COMMUNICATED FROM THE CUSTOMER ON (B)(6) 2015 CONFIRMS THERE WAS CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE ELEVATED ACCESS ACCUTNI+3 RESULTS, AS TWO (2) OF THE PATIENTS WERE TREATED AND THEN TRANSFERRED TO AN ALTERNATE LOCATION. ONE OF THESE PATIENTS WAS RELEASED FROM THE ALTERNATE LOCATION, AND THE OTHER WAS ADMITTED TO THE ALTERNATE LOCATION FOR OTHER REASONS. NO ADDITIONAL INFORMATION REGARDING HOW THE PATIENTS WERE TREATED WAS PROVIDED BY THE CUSTOMER. THIS REPORT ADDRESSES THE ADVERSE EVENT OF TREATMENT AND TRANSFER TO AN ALTERNATE LOCATION FOR ONE (1) PATIENT. MDR 2122870-2015-00421 ADDRESSES THE ADVERSE EVENT OF TREATMENT AND TRANSFER TO AN ALTERNATE LOCATION FOR A SECOND PATIENT. MDR 2122870-2015-00422 ADDRESSES AN UNKNOWN NUMBER OF PATIENTS WHICH DID NOT EXPERIENCE A CHANGE OR IMPACT TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN ASSOCIATION WITH THE ELEVATED ACCESS ACCUTNI+3 RESULTS. QUALITY CONTROL (QC) AND SYSTEM CHECK PARAMETERS WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS AT THE TIME OF THE EVENT. INFORMATION REGARDING THE COLLECTION AND CENTRIFUGATION OF THE SAMPLES WAS NOT PROVIDED BY THE CUSTOMER. NO ISSUES WITH SAMPLE INTEGRITY WERE NOTED BY THE CUSTOMER. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS INSTRUMENT PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454978 ACCESS 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O