BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 2003419 · Received March 1, 2011

    Report

    Report Number
    2122870-2011-00505
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 30, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACCUTNI SAMPLE WAS COLLECTED IN A BD LIHEP PLASMA TUBE. THE CUSTOMER STATED TO CLOSE TUBE ACCESSION (CTA)THAT THE SAMPLES ARE ANALYZED FROM THE PRIMARY CONTAINER THROUGH THE CTA.. PER THE CUSTOMER SUPPLIED DOCUMENTATION: QC DATA, ALL THREE LEVELS OF ACCUTNI QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. ROUTINE SYSTEM CHECKS WERE PERFORMED ON (B)(6) 2011; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A BCI FIELD SERVICE ENGINEER (FSE) DISCOVERED A SLIGHT KINK IN THE SUBSTRATE PROBE AND REPLACED THE PROBE. FSE PERFORMED THE FOLLOWING: REBUILT THE SUBSTRATE PUMP, DECONTAMINATED THE SUBSTRATE SYSTEM AND PRIMED THE SUBSTRATE. THE FSE PERFORMED THE SUBSTRATE PORTION OF THE SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE FSE PERFORMED A FULL SYSTEM CHECK WHICH FAILED THE WASHED PORTION. THE FSE DISCOVERED A LARGE AMOUNT OF BUBBLES IN THE WASH PUMP SO THE FSE REBUILT THE WASH PUMP AND PERFORMED ANOTHER SYSTEM CHECK; IT FAILED THE WASHED PORTION AGAIN. REMOVED THE ANALYTICAL MODULE AND CLEANED THE WASH WHEEL, REPLACED THE ROLLERS AND MIXER ROLLER ASSEMBLIES, THE MIXER BELT, THE ASPIRATE PROBES AND THE PERI-PUMP TUBING. PERFORMED THE ROUTINE SYSTEM CHECK AGAIN WHICH FAILED ON (B)(4) 2011 FSE REBUILT THE PRECISION PUMP, VERIFIED ALL THE CONNECTIONS ON THE FLUIDICS MANIFOLD, REMOVED AND REPLACED THE WASH BUFFER WITH FRESH WASH BUFFER AND PRIMED THE SYSTEM. FSE PERFORMED A ROUTINE SYSTEM CHECK AND A HIGH SENSITIVITY SYSTEM CHECK; BOTH PASSED WITHIN INSTRUMENT SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED TO DATE FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS ACCUTNI RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR ONE PATIENT, GENERATED BY ACCESS 2I (LXI) IMMUNOASSAY SYSTEM. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS REPEATED ON THE SAME UNIT AND AN ALTERNATE UNIT AND LOWER RESULTS WITHIN NORMAL REFERENCE RANGE WAS OBTAINED. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT DEATH OR INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Description of Event or Problem · 1

    N/A

    Description of Event or Problem · 1

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2I (LXI) IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. ACCESS2 LXI N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR