BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    MDR report key: 2183669 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-01133
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    July 21, 2008
    Report Date
    July 29, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VITAMIN B12 CALIBRATION AND QUALITY CONTROL (QC) WERE BOTH WITHIN SPECS ON (B)(6) 2008 BEFORE THIS EVENT OCCURRED. ON (B)(6) 2008, A TECH INVERTED AN OPENED REAGENT PACK BEFORE PLACING IT BACK ONTO THE INSTRUMENT. THE FOLLOWING MORNING ON (B)(6) 2008, LEVEL 3 QC FAILED TO MEET SPECS TWICE. CUSTOMER THEN RECALIBRATED VITAMIN B12 ON (B)(6) 2008 AT 11:03. BOTH LEVELS OF QC WERE WITHIN SPECS AFTER THE NEW CALIBRATION. SVC WAS NOT DISPATCHED FOR THIS EVENT. CUSTOMER ERROR DUE TO INVERTING AN OPENED REAGENT PACK IS THE ROOT CAUSE OF THIS EVENT. PER PRODUCT LABELING: "MIX THE NEW, UNPUNCTURED REAGENT PACK BY GENTLY INVERTING THE PACK TO REMOVE ANY MAGNETIC PARTICLES FROM THE TOP. NEVER INVERT A PUNCTURED PACK." THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW VITAMIN B12 TEST RESULTS OF 0 PG/ML WERE OBTAINED FOR THREE PTS WHILE USING THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYS. THE ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. THE TESTS WERE REPEATED AND CORRECT RESULTS WERE REPORTED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS VITAMIN B12 ASSAY