BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT I2000SR ANALYZER

    MDR report key: 3070807 · Received April 22, 2013

    Report

    Report Number
    1628664-2013-00107
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JLW
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, TROUBLE SHOOTING WAS PERFORMED, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. DURING TROUBLESHOOTING OF THE INSTRUMENT THE SAMPLE PROBE WAS REPLACED. THE CUSTOMER CONSIDERED THE SAMPLE PROBE REPLACEMENT TO HAVE RESOLVED THE REPORTED FALSELY DECREASED RESULT ISSUE. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT I2000 SR ANALYZER, LIST NUMBER 03M74 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY DECREASED ARCHITECT TSH RESULT. THE CUSTOMER INDICATED AN INITIAL RESULT OF 0.02 AND A RETEST RESULT OF 2.74. THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172370 ARCHITECT I2000SR ANALYZER JLW ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT TSH| LN 07K62-20, SN (B)(4)| ARCHITECT TSH| LN 07K62-20, SN (B)(4)