BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CALCIUM

    MDR report key: 3853754 · Received June 6, 2014

    Report

    Report Number
    1628664-2014-00109
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    February 25, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJY
    PMA / PMN Number
    K981578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED CALCIUM IMPRECISION FOR PATIENT SAMPLES TESTED ON THE ARCHITECT C16000 ANALYZER. THE CUSTOMER WAS NOT CENTRIFUGING THE SAMPLES PER MANUFACTURER RECOMMENDATION. THE CALCIUM PACKAGE INSERT AND ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDE ADEQUATE LABELING FOR THE CUSTOMER'S ISSUE. COMPLAINT DATABASE SEARCHES WERE PERFORMED AGAINST THE CUSTOMER'S CALCIUM REAGENT LOT 65426UN13 AND NO OTHER COMPLAINT TICKETS WERE FOUND. A REVIEW OF COMPLAINT TRENDING OVER THE LAST 12 MONTHS INDICATED NO ADVERSE OR NON-STATISTICAL TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. BASED ON THE DATA AVAILABLE AND THE RESULTS OF THIS EVALUATION, NO PRODUCT DEFICIENCY OR MALFUNCTION WERE IDENTIFIED WITH CALCIUM REAGENT LOT 65426UN13.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED CALCIUM IMPRECISION FOR PATIENT SAMPLES TESTED ON THE ARCHITECT C16000 ANALYZER. SAMPLE ID (B)(4) GENERATED RESULTS OF 2.538, 3.223, 4.635, 3.093 AND 3.167 MMOL/L. THE RESULT OF 4.635 MMOL/L IS ABOVE THE NORMAL RANGE AND THE RESULT OF 2.538 MMOL/L IS WITHIN THE NORMAL RANGE OF 2.10 - 2.55 MMOL/L. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332446 CLINICAL CHEMISTRY CALCIUM CALCIUM CJY ABBOTT MANUFACTURING INC 65426UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16000 SYSTEM| LIST 03L77-01, SERIAL (B)(4)| LIST 03L77-01, SERIAL (B)(4)| ARCHITECT C16000 SYSTEM