BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 5793173 · Received July 14, 2016

    Report

    Report Number
    3008754095-2016-00026
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 10, 2016
    Manufacturer
    ORGENICS LTD
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    120037/0
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVES A REPORTED (B)(6) RESULT ON THE AB LINE. THE PATIENT WAS CONFIRMED (B)(6) VIA MULTISPOT/(B)(6) QUAL AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: · THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING KIT LOT # 151215 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. · HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT # 151215 WERE REVIEWED. ALL QUALITY CONTROL RELEASE TESTING WAS VALID AND PERFORMED WITHIN SPECIFICATIONS WITH NO OBSERVED ANOMALIES NOTED. BASED ON THE RESULTS OF THE INVESTIGATION, ORGENICS WAS NOT ABLE TO CONFIRM THE REPORTED COMPLAINT OR DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, A POTENTIAL CAUSE IN THIS CASE MAY BE THE PRESENCE OF A SUBSTANCE WITHIN THE SAMPLE THAT COULD HAVE INFLUENCED THE TEST RESULTS, SUCH AS; TOXOPLASMA IGG, HUMAN ANTI-MOUSE ANTIBODIES, RHEUMATOID FACTOR, ELEVATED TRIGLYCERIDES, OR (B)(6). AS STATED IN THE WARNINGS SECTION OF THE PRODUCT INSERT FOR THE ALERE DETERMINE (B)(6) COMBO: "SPECIMENS FROM INDIVIDUALS WITH TOXOPLASMA IGG, HUMAN ANTI-MOUSE ANTIBODIES, RHEUMATOID FACTOR, ELEVATED TRIGLYCERIDES (ABOVE 600 MG/DL), (B)(6) INFECTION, HOSPITALIZED AND CANCER PATIENTS MAY GIVE FALSE POSITIVE TEST RESULTS." CORRECTIVE ACTION / PREVENTIVE ACTION (CAPA) INVESTIGATION (INTERNAL REFERENCE (B)(4)) HAS BEEN COMPLETED FOR FURTHER INVESTIGATION OF REOCCURRING FALSE POSITIVE RESULTS WHEN TESTING LABOR AND DELIVERY SAMPLES. (B)(4) ASSESSED THE SIGNIFICANCE OF THE FALSE POSITIVE RATES TO THE SAFETY AND EFFECTIVENESS OF THE TEST IN PREGNANT AND LABOR AND DELIVERY PATIENTS. INVESTIGATION CONCLUSIONS MADE WITHIN THE CAPA INDICATE THAT ALERE DETERMINE (B)(6) COMBO PRODUCES RESULTS WITHIN THE RANGE EXPECTED AS MENTIONED IN THE PRODUCT PI AND HAS PERFORMED SIMILARLY WITH ANOTHER FDA-APPROVED 4TH GENERATION TEST IN A COMPARABLE FIELD STUDY. BASED ON THE ABOVE, THERE IS NO EVIDENCE TO SUGGEST A PRODUCT DEFICIENCY AND THE INVESTIGATION IS DEEMED CLOSED. THE TREND WILL BE FURTHER MONITORED AND TRACKED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL (B)(6) RESULT FOR A LABOR AND DELIVERY PATIENT. CONFIRMATORY TESTING WAS PERFORMED AND THE RESULT WAS (B)(6). DUE TO (B)(6) RESULT THE PATIENT UNDERWENT A C-SECTION. THERE WERE NO REPORTED COMPLICATIONS DUE TO THE C-SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447971 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD 151215 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization