BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2834159 · Received November 15, 2012

    Report

    Report Number
    2122870-2012-01895
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CDZ
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES GENERATING THE IND FLAGGED RESULTS ALL HAD RELATIVE LIGHT UNIT (RLU) VALUES GREATER THAN 2.5 MILLION RLUS WHICH WERE HIGHER THAN THE MEAN S0 RLU VALUE OF THE ACTIVE TESTOSTERONE CALIBRATION CURVE 1.9 MILLION RLUS. THE CUSTOMER REPORTED QC WAS PERFORMING WITHIN THEIR ESTABLISHED LIMITS ON THE (B)(6). SYSTEM CHECKS WERE ALSO PASSING ON THE (B)(6) AFTER THE FIRST PATIENT SAMPLE HAD PRODUCED THE IND FLAGGED RESULTS. SAMPLE HANDLING INFORMATION HAS NOT BEEN SUPPLIED. HOTLINE INDICATED THERE WERE NO ISSUES OBSERVED IN THE INSTRUMENT EVENT LOG OCCURRING FROM THE TIME THE ERRONEOUS RESULTS HAD BEEN GENERATED SO ONSITE SERVICE WAS DISPATCHED TO THE CUSTOMER SITE. A FIELD SERVICE ENGINEER (FSE) OBSERVED ISSUES AFTER THE FSE PERFORMED A HIGH SENSITIVITY (HS) SYSTEM CHECK IN WHICH 3 OUT OF 100 TEST RESULTS GENERATED QUANTITY NOT SUFFICIENT FLAGS (QNS). THE FSE NOTED THE SAMPLE CUPS APPEARED TO BE PROPERLY FILLED AND SHOULD NOT HAVE GENERATED THE QNS FLAGS WHEN THEY WERE DOUBLE CHECKED AFTER THE HS SYSTEM CHECK HAD COMPLETED. THE FSE CHECKED THE TRANSDUCER AND OBSERVED THE TRANSDUCER WAS "TURNED" OR NOT PROPERLY SEATED IN ITS HOUSING AND THE VOLTAGE WAS AT 109V. THE FSE THEN ADJUSTED THE TRANSDUCER ALIGNMENT IN THE HOUSING AND THE VOLTAGE WAS THEN AT 207V. THE FSE DID NOT NOTE FURTHER ADJUSTMENTS WERE MADE TO ULTRASONIC VOLTAGE SETTINGS BUT THEY DID REPORT THAT A WET/ DRY SERVICE ASSAY FAILED FOR ELEVATED %CV VALUES SO THE FSE ORDERED A NEW TRANSDUCER WHICH WAS REPLACED BY THE FSE THE FOLLOWING DAY. A CLEANING PROTOCOL ON THE INSTRUMENT WAS PERFORMED AND THEN A PASSING SYSTEM CHECK AND PASSING QC WERE PERFORMED TO VERIFY THE INSTRUMENT PERFORMANCE WAS ACCEPTABLE. HARDWARE IS THE LIKELY CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) TO REPORT THEY HAD OBTAINED 'NO VALUE' INDETERMINATE (IND) FLAGGED TESTOSTERONE PATIENT RESULTS ON THEIR ACCESS 2 ANALYZER FOR THREE DIFFERENT PATIENTS OCCURRING ON TWO SEPARATE DATES ((B)(6)). THE CUSTOMER INDICATED THEY SENT OUT ONE OF THE PATIENT SAMPLES (PATIENT 1) TO QUEST LABS AND THEY WERE ABLE TO OBTAIN A TESTOSTERONE RESULT OF 818 NG/DL USING AN UNSPECIFIED METHOD. THE CUSTOMER INDICATED THIS ISSUE HAD ONLY IMPACTED THREE PATIENTS' SAMPLES; OTHER PATIENT'S SAMPLES WERE GENERATING QUANTIFIABLE TESTOSTERONE RESULTS FROM THE SAME TIME FRAME THAT WERE NOT PROBLEMATIC OR IN QUESTION. THERE WERE NO CHANGES IN PATIENT TREATMENT OR AFFECTS TO ANY PATIENT IN CONNECTION TO THIS EVENT. THIS MDR IS BEING SUBMITTED FOR PATIENT RESULTS OCCURRED ON (B)(6) 2012. AN MDR 2122870-2012-01894 IS COVERING PATIENT RESULTS GENERATED ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1