BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT TSH

    MDR report key: 956836 · Received November 30, 2007

    Report

    Report Number
    1415939-2007-00260
    Event Type
    Other
    Date Received
    November 30, 2007
    Date of Event
    November 10, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JLW
    PMA / PMN Number
    K983442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE PT PRESENTED WITH A WOUND TO THE HEAD WITH ALTERED MENTAL STATUS AND A POSSIBLE HEART CONDITION. THE PT HAD PREVIOUSLY BEEN DIAGNOSED WITH LEUKOCYTOSIS AND DIABETES AND TAKING DIGOXIN AND LOVENOX. AN INITIAL DRAW (2007 @ 23:45) GENERATED AN ARCHITECT I2000 TSH RESULT OF 13.1 MIU/ML (THIS SAMPLE RETESTED AT 13.8 MIU/ML). A SECOND DRAW (THE NEXT DAY @ 08:40) GENERATED A RESULT OF 3.03 MIU/ML. A THIRD DRAW (SAME DAY @ 16:45) GENERATED A RESULT OF 1.63 MIU/ML. A FINAL DRAW THE FOLLOWING DAY @ 05:30) GENERATED A RESULT OF 1.89 MIU/ML. A PHYSICIAN QUESTIONED THE INITIAL ELEVATED RESULT. ALL RESULTS WERE PERFORMED ON HEPARINIZED PLASMA SAMPLES AND ALL CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THE PT WAS NOT TREATED FOR ANY THYROID CONDITION. TREATMENT CONSISTED OF ATTENTION FOR THE HEAD WOUND, IV FLUIDS AND POSSIBLE AMI ISSUES. THERE IS NO FURTHER IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TSH CMIA FOR THE QUANTITATION OF HUMAN TSH JLW ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR ARCHITECT I2000 ANALYZER LIST # 3M74-01