BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CALCIUM

    MDR report key: 1710066 · Received June 4, 2010

    Report

    Report Number
    2018433-2010-00104
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 13, 2010
    Report Date
    May 25, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CJY
    PMA / PMN Number
    K981578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.ARC C16000 ANALYZER LN:3L77-01 (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A HEMODIALYSIS PATIENT GENERATED ARCHITECT C16000 CALCIUM ASSAY RESULTS OF 18.2 AND 17.3 MG/DL, WHICH WERE INCONSISTENT WITH THE PATIENT'S HISTORY. THESE RESULTS WERE NOT REPORTED FROM THE LAB. THE SAMPLE WAS RETESTED AND GENERATED RESULTS OF 10.3, 10.3, 10.2, 10.0 AND 9.9 MG/DL. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY CALCIUM FOR THE QUANTITATION OF CALCIUM IN HUMAN SERUM, PLASMA OR URINE CJY ABBOTT MANUFACTURING, INC. 83063HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C16000 ANALYZER LN:3L77-01 (B)(4)| ARC C16000 ANALYZER LN:3L77-01 (B)(4)