BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1023672 · Received April 1, 2008

    Report

    Report Number
    1628664-2008-00083
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    DHA
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED AN ARCHITECT B-HCG ASSAY RESULT OF 1900 MIU/ML. A SECOND SAMPLE WAS DRAWN ONE WEEK LATER AND GENERATED, AND ARCHITECT B-HCG ASSAY RESULT OF <1.2 MIU/ML. THE INITIAL SAMPLE WAS THEN RETESTED AND GENERATED A RESULT OF <1.2 MIU/ML. UPON TROUBLESHOOTING, IT WAS DISCOVERED THAT WHEN THE INITIAL SAMPLE WAS FIRST TESTED, IT WAS PRECEDED BY A SAMPLE THAT GENERATED AN ARCHITECT B-HCG ASSAY RESULT OF 30,000 MIU/ML. THE CUSTOMER SUSPECTS A CARRYOVER ISSUE WITH THE ANALYZER (THE SAMPLE PROBE HAS BEEN ON THE ANALYZER FOR THREE MONTHS). THERE IS NO IMPACT TO PT MANAGEMENT REPORTED. AN INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER DHA ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT#: 55936JN00| ARCHITECT B-HCG ASSAY LIST#: 7K78-20