BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2110555 · Received June 1, 2011

    Report

    Report Number
    2122870-2011-01639
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION INFORMATION HAS NOT BEEN SUPPLIED TO DATE. PER THE CUSTOMER SUPPLIED QC DATA, THE ACCUTNI QC WAS WITHIN THE ESTABLISHED RANGES ON (B)(6) 2011 PRIOR TO THE EVENT, BUT BOTH THE LEVEL 1 AND LEVEL 3 ACCUTNI QC FAILED OUT OF RANGE HIGH AFTER THE EVENT. ON THE NEXT MORNING OF (B)(6) 2011, THE CUSTOMER HAD MULTIPLE QC FAILURES ACROSS SEVERAL ASSAYS. THE CUSTOMER ATTEMPTED TO RECALIBRATE THE ACCUTNI ASSAY AFTER THE EVENT ON (B)(6) 2011 BUT BOTH CALIBRATION ATTEMPTS FAILED. BCI SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER HAS THEIR OWN BIOMED ENGINEER (BME). BCI CUSTOMER TECHNICAL SUPPORT (CTS) WORKED WITH THE ON-SITE BME TO TROUBLESHOOT THE INSTRUMENT. THE BME REPLACED ONE OF THE ASPIRATE PROBES AND ALL OF THE PERI-PUMP TUBING. IT WAS NOTED AFTER REMOVING THE TUBING THAT THERE WAS A HOLE NEAR ONE OF THE GREY CLIPS FOR ASPIRATE PROBE #2. THE BME THEN PRIMED THE SYSTEM AND PERFORMED A ROUTINE SYSTEM CHECK, WHICH PASSED WITHIN THE INSTRUMENT SPECIFICATIONS. THE CUSTOMER PERFORMED ASSAY QC THE NEXT MORNING AND DID NOT NOTE ANY ISSUES. HARDWARE WAS THE ROOT CAUSE FOR THE EVENT. CUSTOMER HAS BIOMED ENGINEER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO HIGHER THAN EXPECTED TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE AND ABOVE AMI CUTOFF, GENERATED BY ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. SUBSEQUENT TESTING ON AN ALTERNATE INSTRUMENT PRODUCED LOWER RESULTS EITHER WITHIN THE RISK STRATIFICATION RANGE OR WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORTS OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1