BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 5603811 · Received April 25, 2016

    Report

    Report Number
    3008754095-2016-00011
    Event Type
    Malfunction
    Date Received
    April 25, 2016
    Date of Event
    February 2, 2016
    Report Date
    February 16, 2016
    Manufacturer
    ORGENICS LTD
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    120037/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVED A REPORTED (B)(6). THE CONFIRMATORY TESTS WERE PERFORMED AND THE (B)(6). AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING A KIT LOT # 150816 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT #150816 WERE REVIEWED. ALL QUALITY CONTROL RELEASE TESTING WAS VALID AND PERFORMED WITHIN SPECIFICATIONS WITH NO OBSERVED ANOMALIES NOTED DETERMINE COMBO KIT STRIPS WERE RECEIVED FROM THE COSTUMER. ALL QC SAMPLES GAVE RESULTS ACCORDING TO QC SPECIFICATIONS. NO (B)(6) WERE OBSERVED. BASED ON THE RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. THE INSTRUCTION FOR USE UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "A (B)(6)".

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL (B)(6) RESULT WHEN TESTED WITH DETERMINE COMBO. THE PATIENT HAD A SERIES OF (B)(6) ACCORDING TO THE FOLLOWING TIMELINE: ON (B)(6) 2015 (B)(6) TEST WAS PERFORMED (THE METHOD WAS NOT PROVIDED) , THE (B)(6) WAS REPORTED TO THE HEALTH DEPARTMENT FOR PATIENT NOTIFICATION. ON (B)(6) 2016 DETERMINE COMBO TEST WAS PERFORMED WHICH SHOWS (B)(6). FOLLOWING THE (B)(6), THE SAMPLE WAS TESTED WITH ABBOT AB/AG, MULTISPOT AND GENIUS , WHICH ALL GAVE (B)(6) THAT WAS OBTAINED ON (B)(6) 2016. ON (B)(6) 2016 VIRAL LOAD WAS PERFORMED AND REPORTED (B)(6) AS WELL, RNA QTY COPIES/ML WAS (B)(6). IT WAS REPORTED THAT DUE TO (B)(6) THE PATIENT DIDN'T REFER TO (B)(6) CARE ON (B)(6) 2016 AND AFTER CONFIRMATORY (B)(6) OBTAINED IT WAS DIFFICULT TO GET IN CONTACT WITH THE PATIENT. THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261203 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD 150816 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR