BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 1423457 · Received July 30, 2009

    Report

    Report Number
    1628664-2009-00287
    Event Type
    Malfunction
    Date Received
    July 30, 2009
    Date of Event
    July 7, 2009
    Report Date
    July 7, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    DHA
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION WAS PERFORMED ON THE ARCHITECT ANALYZER, LIST NUMBER 3M74-01, (B)(4) AND DETERMINED THAT IT WAS PERFORMING ACCEPTABLY. A REVIEW OF THE COMPLAINT TEXT INDICATED THAT A DILUTED SAMPLE WAS RUN AND A (B)(4) RESULT OF (B)(4) WAS TRANSMITTED TO THE CUSTOMER'S HOST LABORATORY INFORMATION SYSTEM (LIS) WITHOUT THE < SIGN. NO SAMPLE IDENTIFICATION NUMBER OR RUN DATE/TIME WAS PROVIDED. A REVIEW OF ALL (B)(4) RESULTS CAPTURED IN THE CUSTOMER'S RESULTS LOG WAS PERFORMED. A TOTAL OF (B)(6) RESULTS WERE CAPTURED IN THE LOG. NO RESULTS OF <5.0 OR <7000 WERE FOUND IN THE LOG. COMPLAINT TRENDING WAS REVIEWED AND NO SIMILAR COMPLAINTS WERE FOUND. THE ARCHITECT SYSTEM OPERATION MANUAL WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS HOST CONFIGURATION AND TROUBLESHOOTING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY. THIS IS THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT ANALYZER GENERATED AN INITIAL B-HCG RESULT OF <7000 U/L. A NEW SAMPLE WAS OBTAINED AND A NEGATIVE RESULT WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT (B)(4) REAGENT 7K78| ARCHITECT (B)(4) REAGENT 7K78