BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 6452692 · Received April 3, 2017

    Report

    Report Number
    3008754095-2017-00002
    Event Type
    Malfunction
    Date Received
    April 3, 2017
    Date of Event
    February 4, 2017
    Report Date
    February 28, 2017
    Manufacturer
    ORGENICS LTD
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    120037/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVED A POTENTIAL (B)(6) RESULT. THE CONFIRMATION TEST INDICATED A (B)(6) RESULT HOWEVER THE METHOD IS CURRENTLY UNKNOWN. AN ATTEMPT TO GATHER ADDITIONAL INFORMATION WAS MADE HOWEVER, PATIENT DETAILS ARE CURRENTLY NOT AVAILABLE. AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT # 160707 WERE REVIEWED. NO NOTES REGARDING THE SPECIFIC COMPLAINT OF (B)(6) WERE FOUND. ALL QUALITY CONTROL RELEASE TESTING WAS VALID AND PERFORMED WITHIN SPECIFICATIONS. DUE TO LACK OF INFORMATION REGARDING THIS CASE, ORGENICS WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE. AS STATED IN THE PI:"LIMITATION OF THE TEST", SECTION; "A (B)(6) RESULT DOES NOT PRECLUDE THE POSSIBILITY OF EXPOSURE TO (B)(6) OR INFECTION WITH (B)(6) ." A (B)(6) RESULT MEANS THAT (B)(6) ANTIBODIES OR P24 ANTIGEN WERE NOT DETECTED IN THE SAMPLE AT THE TIME OF TESTING. SINGLE USE DEVICE.

    Description of Event or Problem · 1

    THIS COMPLAINT INVOLVES A POTENTIAL (B)(6) RESULT. THE CONFIRMATION TEST INDICATED A (B)(6) RESULT HOWEVER THE METHOD IS CURRENTLY UNKNOWN. AN ATTEMPT TO GATHER ADDITIONAL INFORMATION WAS MADE HOWEVER, PATIENT DETAILS ARE CURRENTLY NOT AVAILABLE. OCCURING TO THE CURRENT DATA PROVIDED THIS EVENT WAS ASSOCIATED WITH NO REPORTED IMPAIRMENT OF THE BODY, ADVERSE PATIENT OUTCOMES OR FURTHER SPREAD OF THE VIRUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235951 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD 160707 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1