BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 5663064 · Received May 18, 2016

    Report

    Report Number
    3008754095-2016-00015
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Date of Event
    February 19, 2016
    Report Date
    April 7, 2016
    Manufacturer
    ORGENICS LTD
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    120037/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVES A REPORTED FALSE POSITIVE RESULT ON THE AG LINE. THE PATIENT WAS CONFIRMED NON-REACTIVE VIA PCR. AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: · THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING KIT LOT # 151112 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT # 151112 WERE REVIEWED. ALL QUALITY CONTROL RELEASE TESTING WAS VALID AND PERFORMED WITHIN SPECIFICATIONS WITH NO OBSERVED ANOMALIES NOTED. RETURNED PATIENT SAMPLE WAS TESTED WITH RETENTION PRODUCT FOR THE GIVEN LOT. THE POSITIVE AG LINE WAS ABLE TO BE REPLICATED ON A RETENTION SAMPLE OF THE SAME PRODUCT LOT. 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 HIV-1/2 AG/AB COMBO: "SPECIMENS FROM INDIVIDUALS WITH TOXOPLASMA IGG, HUMAN ANTI-MOUSE ANTIBODIES, RHEUMATOID FACTOR, ELEVATED TRIGLYCERIDES (ABOVE 600 MG/DL), HERPES SIMPLEX VIRUS INFECTION, HOSPITALIZED AND CANCER PATIENTS MAY GIVE FALSE POSITIVE TEST RESULTS." CORRECTIVE ACTION / PREVENTIVE ACTION (CAPA) INVESTIGATION (INTERNAL REFERENCE CAPA (B)(4)) HAS BEEN COMPLETED FOR FURTHER INVESTIGATION OF REOCCURRING FALSE POSITIVE RESULTS WHEN TESTING LABOR AND DELIVERY SAMPLES. CAPA (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 HIV-1/2 AG/AB 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). THERE WERE NO ADVERSE PATIENT OUTCOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318071 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD 151112 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1