BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 3770201 · Received April 24, 2014

    Report

    Report Number
    3002809144-2014-00121
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, ACCURACY TESTING, A SEARCH FOR SIMILAR COMPLAINTS, MANUFACTURING RECORDS, AND A REVIEW OF LABELING. A RETAINED REAGENT KIT OF LOT 36077LI00 WAS TESTED FOR SPECIFICITY ACCURACY. RESULTS OF THE SPECIFICITY TESTING SHOWED NORMAL PERFORMANCE WITHOUT (B)(6) RESULTS FOR LOT 36077LI00. A REVIEW OF COMPLAINTS DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR LOT 36077LI00. REVIEW OF THE PRODUCT LABELING CONCLUDED THAT THE (B)(6) RESULTS ARE SUFFICIENTLY ADDRESSED. MANUFACTURING RECORDS WERE REVIEWED FOR LOT 36077LI00 AND THERE WERE NO ISSUES IDENTIFIED. THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION, SINCE POTENTIAL (B)(6) RESULTS WERE OBTAINED FOR TWO DISCREET SAMPLES ON ONE PATIENT. BASED ON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE PRODUCT IS PERFORMING ACCEPTABLY.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED (B)(6) RESULTS ON ONE PATIENT. THE RESULTS PROVIDED FOR (B)(6). PATIENT SAMPLE WAS SENT FOR WESTERN BLOT = (B)(6). ON (B)(6) 2014, A NEW SAMPLE WAS DRAWN ON THIS PATIENT DUE TO EXPOSURE BY A HOSPITAL EMPLOYEE, AND THE ARCHITECT (B)(6) RESULTS WERE AGAIN (B)(6). THE HOSPITAL NURSE HAD A CUT ON AN INDEX FINGER AND WAS NOT WEARING GLOVES WHILE SHE CLEANED A DRESSING ON THE PATIENT. THE CUT ON THE NURSE'S INDEX FINGER CAME INTO CONTACT WITH THE PATIENT'S BLOOD. THE NURSE REQUESTED (B)(6) THERAPY BECAUSE OF THE (B)(6) RESULTS GENERATED BY THE ARCHITECT, THEREFORE, THIS IS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248808 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT GERMANY 36077LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SERIAL # (B)(4)| ARCHITECT I1000SR ANALYZER, LIST # 01L86-01,