BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY CALCIUM

    MDR report key: 2538028 · Received April 17, 2012

    Report

    Report Number
    1628664-2012-00242
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    April 15, 2012
    Report Date
    April 15, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CJY
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER OBSERVED A FALSELY DECREASED CALCIUM RESULT. THE CUSTOMER NOTICED THE REAGENT WAS LOW AND BUBBLES WERE PRESENT. THE CALCIUM REAGENT WAS REPLACED AND THE ISSUE WAS RESOLVED. NO ATYPICAL COMPLAINT ACTIVITY WAS FOUND RELATED TO THE DESCRIBED ISSUE. A REVIEW OF THE PRODUCT LABELING REVEALED THE ISSUE IN QUESTION IS ADEQUATELY ADDRESSED IN THE LABELING CLAIMS. BASED UPON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO SECTION D, SUSPECT MEDICAL DEVICE: BRAND NAME SHOULD BE CLINICAL CHEMISTRY CALCIUM AND CONCOMITANT MEDICAL PRODUCT SHOULD BE ARCHITECT C8000 SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4), FALSE POSITIVE RESULT (B)(4), NO CONSEQUENCES OR IMPACT TO PATIENT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT C8000 ANALYZER GENERATED A FALSELY DECREASED CALCIUM RESULT FOR ONE PATIENT SAMPLE. THE ANALYZER GENERATED AN INITIAL CALCIUM RESULT OF 5.0, AND REPEAT RESULTS OF 10.0 AND 10.1. THE FALSELY DECREASED RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY CALCIUM CALCIUM CJY ABBOTT MANUFACTURING INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 CC CALCIUM REAGENT LN 03L79-21 LOT UNKNOWN