BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM

    MDR report key: 2853433 · Received November 30, 2012

    Report

    Report Number
    2122870-2012-01942
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JLB
    PMA / PMN Number
    K023764
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABORATORY UTILIZES 5 ML BD LITHIUM HEPARIN PLASMA SEPARATOR TUBES WITH GEL FOR CK-MB SAMPLE COLLECTIONS. THE CUSTOMER CENTRIFUGES CK-MB SAMPLES FOR 3 MINUTES AT AMBIENT TEMPERATURE IN A STAT SPAN EXPRESS 4 CENTRIFUGE. THE CUSTOMER DECLINED TO PROVIDE CENTRIFUGATION SPEED. PER CUSTOMER, THE SAMPLE WAS PROCESSED WITHIN ONE HOUR OF COLLECTION. THE CUSTOMER PROVIDED SYSTEM CHECK DATA FROM (B)(6) 2012; ALL SYSTEM CHECK PARAMETERS WERE PASSING WITHIN SPECIFICATIONS. NO EVENT LOG MESSAGES WERE GENERATED IN CONNECTION WITH THIS EVENT. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE ADJUSTED PIPETTOR TEMPERATURES AND VERIFIED PIPETTOR ALIGNMENTS. THE FSE PERFORMED A SYSTEM CHECK AND HIGH SENSITIVITY SYSTEM CHECK; BOTH SYSTEM CHECKS PASSED FOR ALL PARAMETERS WITHIN SPECIFICATION. THE FSE VERIFIED THAT CK-MB PRECISION WAS WITHIN SPECIFICATION AND VERIFIED THAT THE CUSTOMER'S QC WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS. THE INSTRUMENT WAS VERIFIED AS PERFORMING TO PUBLISHED PERFORMANCE SPECIFICATIONS. A CAUSE FOR THIS EVENT COULD NOT BE DETERMINED WITH THE INFORMATION SUPPLIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED MULTIPLE OCCURRENCES OF ERRONEOUS AND/OR IMPRECISE CREATINE KINASE-MB (CK-MB) RESULTS ON TWO PATIENT SAMPLES TESTED ON UNICEL DXL 600 ACCESS IMMUNOASSAY SYSTEM. THIS REPORT IS TO DOCUMENT CKMB RESULTS FOR PATIENT # (B)(6). THE CUSTOMER STATED THE RESULTS FOR THIS PATIENT WERE OBTAINED FROM SERIAL COLLECTIONS (FOUR SEPARATE SAMPLES WERE COLLECTED). THE CK-MB RESULTS EXHIBITED IMPRECISION OUTSIDE SPECIFICATION, WITH SOME RESULTS WITHIN THE NORMAL REFERENCE RANGE AND SOME ABOVE. THE CUSTOMER'S QC WAS WITHIN THE LABORATORY'S ESTABLISHED LIMITS BEFORE THE EVENT. NO OTHER CK-MB RESULTS OR OTHER ASSAYS WERE IN QUESTION. THE CUSTOMER STATED NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DID NOT REPORT AN EFFECT TO PATIENT OR USER ATTRIBUTED TO OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXL 600 ACCESS® IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JLB BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR