BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT CLINICAL CHEMISTRY ICT CALIBRATOR

    MDR report key: 3971566 · Received July 31, 2014

    Report

    Report Number
    1628664-2014-00155
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JGS
    PMA / PMN Number
    K980367
    Removal / Correction Number
    1628664-07/22/14-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DETERMINED THAT ICT CALIBRATOR LOTS HAVE DECREASED TOTAL PROTEIN CONTENT. THE DECREASED TOTAL PROTEIN CONTENT IS CORRELATED WITH INCREASED AMMONIA LEVELS IN THE CALIBRATORS AMMONIA, A KNOWN INTERFERENT, CAN IMPACT THE PERFORMANCE OF THE ICT MODULES POTASSIUM MEASUREMENT. A PRODUCT CORRECTION LETTER HAS BEEN ISSUED TO THE ICT SERUM CALIBRATOR CUSTOMERS WHO RECEIVED SHIPMENTS OF LOTS 21399UN13, 67873UN13, 74710UN13, 82008UN13, AND 88884UN13. THE LETTER IS INSTRUCTING THE CUSTOMERS THAT THEY CAN CONTINUE USE OF THE LOT IF THE CALIBRATION CURVE FOR POTASSIUM IS VERIFIED WITH AT LEAST TWO LEVELS OF CONTROLS ACCORDING TO ESTABLISHED QUALITY CONTROL REQUIREMENTS FOR THE CUSTOMER LABORATORY. THE LETTER IS ALSO INSTRUCTING THE CUSTOMERS TO RECALIBRATE USING A DIFFERENT CALIBRATOR LOT IF QUALITY CONTROLS FOR THE POTASSIUM ASSAY ARE NOT WITHIN THE ESTABLISHED QUALITY CONTROL REQUIREMENTS OF THE CUSTOMER LABORATORY (NEW LOTS ARE AVAILABLE) STABILITY MONITORING OF IN-DATE LOTS IS TO BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DROP IN THE SLOPE OF THE POTASSIUM CURVE AND LOW QUALITY CONTROLS WHILE USING THE ARCHITECT ICT SERUM CALIBRATOR LOT 67873UN13. NO DISCREPANT PATIENT RESULTS OR IMPACT TO PATIENT MANAGEMENT WAS REPORTED. THE ISSUE WAS RESOLVED BY USING THE PREVIOUS ICT CALIBRATOR LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448089 ABBOTT CLINICAL CHEMISTRY ICT CALIBRATOR ICT SERUM CALIBRATOR JGS ABBOTT MANUFACTURING INC 67873UN13

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C16K 03L77-01 SN (B)(4)