BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CALCIUM

    MDR report key: 3140759 · Received May 31, 2013

    Report

    Report Number
    1628664-2013-00144
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJY
    PMA / PMN Number
    K981578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CALIBRATION DATA WAS REVIEWED. THE CUSTOMER INDICATED THAT QC WAS OUT OF RANGE BY GREATER THAN 3SD AND 6SD. THE CUSTOMER TRIED TO CALIBRATE AND HAD ERROR CODE 1455 CALIBRATION FAILURE, CALIBRATOR OUT OF ORDER. CSC REVIEWED THE CALIBRATION CURVES AND FOUND ABNORMAL CURVES ON 5/14/13. THE CUSTOMER OPENED A NEW REAGENT LOT AND PERFORMED CALIBRATION. THE CALIBRATION CURVE WAS NORMAL AND QC WAS IN RANGE. PATIENT RESULTS REPEATED WITHIN NORMAL RANGE. CALIBRATION AND RESULT LOGS WERE REVIEWED AND SHOWED THAT THE REAGENT KIT WAS IN USE WITH NO ISSUES FOR A WEEK PRIOR TO HIGH RESULTS AND CALIBRATION FAILURES. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ISSUES OR ADVERSE TRENDS WERE IDENTIFIED. THE CALCIUM REAGENT PACKAGE INSERT AND THE ARCHITECT SYSTEM OPERATIONS MANUAL WERE REVIEWED AND WERE FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION/DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AN ELEVATED CALCIUM RESULT OF 14.8 MG/DL WAS GENERATED. THE SAMPLE WAS REPEATED WITH A RESULT OF 9.9 MG/DL. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241965 CLINICAL CHEMISTRY CALCIUM CJY ABBOTT MANUFACTURING INC 52807UN12

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C4000 ANALYZER 2P24-40| SN (B)(4)| ARCHITECT C4000 ANALYZER 2P24-40| SN (B)(4)