BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT TOXO IGM

    MDR report key: 2182969 · Received July 28, 2011

    Report

    Report Number
    3002809144-2011-00529
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ABBOTT GERMANY
    Product Code
    LOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS GIVEN UNNECESSARY ANTIBIOTICS. NO PATIENT SAMPLE WAS RETURNED BY THE CUSTOMER FOR EVALUATION PURPOSES, THEREFORE, A RETAINED KIT OF THE ARCHITECT TOXO IGM WAS TESTED; A SUCCESSFUL CALIBRATION WAS ACHIEVED AND ALL QUALITY CONTROLS MET SPECIFICATIONS. SPECIFICITY TESTING WAS PERFORMED WITH ADDITIONAL REPLICATES OF THE NEGATIVE QUALITY CONTROL AND NO FALSE REACTIVE RESULTS WERE GENERATED. REVIEW OF ARCHITECT TOXO IGM COMPLAINT RECORDS FOR REAGENT LOT 03074L100 DID NOT IDENTIFY ANY PROBLEMS RELATING TO FALSE POSITIVE PATIENT RESULTS, THEREFORE, ARCHITECT TOXO IGM REAGENT LOT 03074L100 WAS PERFORMING ACCEPTABLY.

    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 GENERATED A FALSELY ELEVATED ARCHITECT TOXO-IGM RESULT OF 1.49 S/CO FROM A PREGNANT WOMAN SERUM SAMPLE WHEN REAGENT LOT 03074L100 WAS IN USE. THE PREGNANT WOMAN HAD BEEN SERIALLY MONITORED THROUGHOUT HER PREGNANCY AND ALL PREVIOUS TOXO- IGG AND IGM RESULTS WERE ALL NON-REACTIVE AS RECENTLY AS (B)(6) 2011. DUE TO THE REPRODUCIBLE ELEVATED ARCHITECT RESULT, THE LABORATORY NOTIFIED THE DOCTOR. THE CUSTOMER ALSO SENT THE SAMPLE TO BE TESTED BY ALTERNATE METHODS WHERE NON-REACTIVE RESULTS WERE GENERATED BY THE AXSYM, VIDAS AND ROCHE ASSAYS. DUE TO THE INITIAL ELEVATED ARCHITECT TOXO-IGM RESULT, INTRAVENOUS ROVAMICINE WAS ADMINISTERED AS PREVENTIVE TREATMENT BECAUSE THE PREGNANT WOMAN WAS APPROACHING THE END OF HER PREGNANCY. THE BABY WAS BORN IN PERFECT HEALTH. THERE WAS NO ADVERSE EVENT TO THE PREGNANT WOMAN OR THE BABY AS A RESULT OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOXO IGM LOL ABBOTT GERMANY 03074L100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ARCHITECT I1000SR ANALYZ,ER, LIST # 1L86-01| ARCHITECT I1000SR, LIST # 1L86-01, SN (B)(4)