BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 6053004 · Received October 25, 2016

    Report

    Report Number
    3008754095-2016-00030
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    September 8, 2016
    Manufacturer
    ORGENICS LTD
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    120037/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVES 4 REPORTED (B)(6) RESULTS ON THE SAME LOT NO. 1060605. THE CONFIRMATORY TESTS PERFORMED ARE AS FOLLOW: (B)(6) RNA BY PCR (B)(6) RESULTS, 4TH GEN ASSAY (B)(6) RESULTS & GENUS (B)(6) RESULTS. AN INVESTIGATION HAS BEEN CONDUCTED BY (B)(4) WITH THE FOLLOWING ACTIVITIES AND RESULTS: THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING KIT LOT # 160605 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT #160605 WERE REVIEWED. ALL QUALITY CONTROL RELEASE TESTING WERE VALID AND PERFORMED WITHIN SPECIFICATIONS WITH NO OBSERVED ANOMALIES NOTED. DUE TO LACK OF INFORMATION REGARDING THIS CASE, (B)(4) 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVES A REPORTED (B)(6) RESULT. THE PATIENT WAS TESTED (B)(6) VIA (B)(6) BY PCR AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING KIT LOT # 160605 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT # 160605 WERE REVIEWED. ALL QUALITY CONTROL RELEASE TESTING WAS VALID AND PERFORMED WITHIN SPECIFICATIONS WITH NO OBSERVED ANOMALIES NOTED. 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. HOWEVER, THIS DOES NOT COMPLETELY RULE OUT THE POSSIBILITY OF INFECTION WITH (B)(6). (B)(6) ANTIBODIES MAY NOT APPEAR UNTIL A FEW MONTHS AFTER INFECTION WITH THE VIRUS. A VERY RECENT INFECTION MAY NOT PRODUCE ENOUGH P24 ANTIGEN OR ANTIBODIES TO BE DETECTED BY THIS TEST.

    Description of Event or Problem · 1

    THIS CASE IS REGARDING 4 (B)(6) RESULTS ON 4 DIFFERENT PATIENTS FOR THE SAME LOT NO. 160605 THE CONFIRMATORY TESTS CONDUCTED FOR THIS CASE ARE AS FOLLOWS; (B)(6) RNA BY PCR (B)(6) RESULTS, 4TH GENERATION ASSAY (B)(6) RESULTS & GENUS (B)(6) - RESULTS. 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
    704429 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD 160605 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1