BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM SERIES II

    MDR report key: 86129 · Received April 17, 1997

    Report

    Report Number
    1628664-1997-00040
    Event Type
    Malfunction
    Date Received
    April 17, 1997
    Date of Event
    July 8, 1996
    Report Date
    April 15, 1997
    Manufacturer
    ABBOTT MFG., INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE SPECTRUM OPERATION WAS DONE, AS WELL AS A PRODUCT LITERATURE CHECK FOR INFO AVAILABLE TO THE CUSTOMER. INSPECTION OF THE TEST PARAMETER FILE SHOWED THAT THE CUSTOMER HAD THE CALIBRATION INTERVAL FOR CALCIUM SET AT 720 HOURS INSTEAD OF THE RECOMMENDED 24 HOURS. IT ALSO FOUND THAT THE UPPER LINEAR LIMIT WAS CORRECTLY SET AT 16 MG/DL. FAILURE TO CALIBRATE CALCIUM AT THE MFR'S SPECIFIED INTERVALS MAY RESULT IN INSTABILITY OF THE CALIBRATION CURVE WHICH CAN AFFECT SAMPLE RESULT VALUES. THE SPECTRUM ANALYZER IS EQUIPPED WITH ADEQUATE SOFTWARE SAFEGUARDS TO PREVENT THE SYSTEM FROM AUTOMATICALLY PRINTING A KNOWN UNACCEPTABLE RESULT. THE REAGENT PACKAGE INSERT ALSO HAS HIGHLIGHTED TEST FOR THE OPERATOR TO ENSURE THAT CRITICAL AND TIMELY INFO, SUCH AS THE CALIBRATION INTERVALS, IS PRESENTED TO THE CUSTOMER AT ALL TIMES. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY DATA ON LOT NUMBERS OF REAGENT IN USE, NO QUALITY CONTROL, NO MAINTENANCE RECORDS, AND WHETHER APPLICABLE ERROR CODES WERE PRESENT OR ABSENT AT THE TIME OF THE INCIDENT, THEREFORE, NO CAUSE CAN BE DETERMINED. EVALUATION COMPLETE-FINAL REPORT.

    Description of Event or Problem · 1

    ON 7/8/96, THE ACCOUNT REPORTED A CALCIUM RESULT OF 18.0 ON A PT WITH MULTIPLE MYELOMA. THE PT WAS SENT TO THE ER ON 7/11/96, AND AN IV INFUSION WAS STARTED. THE IV WAS DISCONTINUED 4 HOURS LATER WHEN THE LAB GAVE NEW RESULTS. A REPEAT TESTING OF THE ORIGINAL SAMPLLE RECOVERED 8.7 AND A NEW SAMPLE RECOVERED 9.1. THE PT HAD BEEN HOSPITALIZED SEVERAL WEEKS PRIOR TO THIS INCIDENT, AND RELEASED WHEN THE ONCOLOGIST DOCUMENTED A CHANGE IN REGIMENT TO BE CARRIED OUT WITH PT ONLY VISITING THE CLINIC FOR CYTOXAN, BCNU, ALKERAN, AND PREDNISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM SERIES II CLINICAL CHEMISTRY ANALYZER LCI ABBOTT MFG., INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other