BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOXO IGM

    MDR report key: 1971910 · Received January 27, 2011

    Report

    Report Number
    1628664-2011-00055
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ABBOTT
    Product Code
    LGD
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT WAS SUBMITTED UNDER BRAND NAME 'ARCHITECT I2000SR ANALYZER', (B)(4). IT WAS DETERMINED THAT THE INVESTIGATION SHOULD BE PERFORMED ON BRAND NAME 'ARCHITECT TOXO IGM' REAGENT, (B)(4). NO SIMILAR PRODUCT IS DISTRIBUTED FOR SALE IN THE UNITED STATES. SECTIONS HAVE BEEN UPDATED TO REFLECT THIS INFORMATION. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, FILE KIT EVALUATION, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETAINED SAMPLE OF ARCHITECT TOXO IGM REAGENT LOT 93796HP00 WAS USED TO TEST ARCHITECT TOXO IGM CALIBRATOR AND CONTROLS. CALIBRATION WAS VALID AND PASSED ACCORDING TO ASSAY FILE SPECIFICATIONS. CONTROLS WERE WITHIN THE SPECIFICATIONS STATED IN THE PACKAGE INSERT. NO FALSE REACTIVE RESULTS WERE OBTAINED. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TREND FOR THE COMPLAINT ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000 SR ANALYZER GENERATED A FALSE POSITIVE TOXO IGM RESULT FOR ONE PATIENT SAMPLE. THE PATIENT HAD PREVIOUSLY TESTED NEGATIVE BUT NOW GENERATED A POSITIVE TOXO IGM RESULT OF 1.0. THE FALSE POSITIVE TOXO IGM RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOXO IGM FOR THE MEASUREMENT OF IGM ANTIBODIES TO TOXOPLASMA GONDII LGD ABBOTT 93796HP00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN 3M74-01 SN (B)(4)