BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX

    MDR report key: 1963175 · Received January 18, 2011

    Report

    Report Number
    2050012-2011-00111
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LCP
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BCI CONTACTED THE CUSTOMER AND THEY STATED QC SHIFTED HIGH BECAUSE OF THE REAGENT WAS NOT STORED PROPERLY. CUSTOMER INDICATED THAT AFTER RECEIVING, THE REAGENT WAS LEFT IN THE SHIPPING BOX AT ROOM TEMPERATURE FOR A FEW DAYS. BY THE TIME THE CUSTOMER OPENED THE BOX, THE GEL ICE PACKS WERE NO LONGER COLD. THEY DISCARDED THE REAGENTS AND USED THE NEW REPLACEMENT LOT. NO ISSUE WAS FOUND ONCE THE NEW REAGENT WAS REPLACED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC., (BCI) THAT HAEMOGLOBIN A1C (HBA1C) QC RESULTS SHIFTED HIGH (2SD) ON SYNCHRON CX9 ALX INSTRUMENT WHEN THE CUSTOMER SWITCHED TO A DIFFERENT REAGENT LOT. THE CUSTOMER HAS CONCERNED ON FOUR DIABETIC PATIENT SAMPLE RESULTS. THESE RESULTS WERE REPORTED OUT OF THE LAB AND THE PHYSICIANS WERE NOTIFIED TO REVIEW THE REPORTED RESULTS. PER CUSTOMER UPDATE, THE HBA1C RESULTS REPORTED OUT TO THE PHYSICIAN WERE THE CORRECT RESULTS. ACTUAL RESULTS WERE NOT SUPPLIED. THERE WAS NO IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL CHEMISTRY ANALYZER LCP BECKMAN COULTER INC. CX9 ALX

    Patients

    Seq Age Sex Outcome Treatment
    1