BEUDAMED
    FDA Adverse Event Other Summary report: N

    C8000 CALCIUM

    MDR report key: 924218 · Received March 27, 2007

    Report

    Report Number
    2018433-2007-00005
    Event Type
    Other
    Date Received
    March 27, 2007
    Date of Event
    February 26, 2007
    Report Date
    March 6, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JFO
    PMA / PMN Number
    k981578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF AN INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A FEMALE PT COMPLAINING OF THIRST WITH SIGNS OF DEHYDRATION AND ON CALCIUM SUPPLEMENTS GENERATED AN INITIAL ARCHITECT C8000 CALCIUM ASSAY RESULT OF 4.4 MMOL/L (17.6 MG/DL). THE SAMPLE WAS RETESTED AND GENERATED A RESULT OF 4.14 MMOL/L (16.56 MG/DL). THE PT WAS HOSPITALIZED AND BLOOD WAS REDRAWN THAT GENERATED A CALCIUM RESULT OF 2.4 MMOL/L (9.6 MG/DL). THE INITIAL SAMPLE WAS THEN RETESTED AND GENERATED A RESULT OF 2.14 MMOL/L (8.56 MG/DL). THE CUSTOMER STATES THAT, THE INITIAL SAMPLE ARRIVED AT THEIR LAB LATE ON A FRIDAY, WAS CENTRIFUGED AND STORED AT 4 DEGREES CENTIGRADE ON GEL OVER THE WEEK-END. THE SAMPLE WAS TESTED THE FOLLOWING MONDAY MORNING. CONTROLS WERE WITHIN SPECS. THE PT WAS RELEASED FROM THE HOSPITAL WITH NO FURTHER IMPACT TO PT MGMT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C8000 CALCIUM CALCIUM JFO ABBOTT MANUFACTURING, INC. NA 44064HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO ARCHITECT C8000 ANALYZER LIST#: 1G06-01