BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 5008688 · Received August 13, 2015

    Report

    Report Number
    3008754095-2015-00007
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 2, 2015
    Manufacturer
    ORGENICS LTD.
    Product Code
    MZF
    UDI-DI
    07290015003735
    PMA / PMN Number
    120037/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVED A REPORTED (B)(6) RESULT OF THE AB LINE. FOLLOWING THE (B)(6) AB RESULT, THE PATIENT TESTED (B)(6) ON (B)(6) ANTIBODY DIFFERENTIATION WITH REFLEX TO (B)(6) RNA, QUALITATIVE TRANSCRIPTION-MEDIATED AMPLIFICATION. AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: - THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING A KIT LOT # 150602 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. - HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT #150602 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 AB LINE WAS ABLE TO BE REPLICATED ON A RETENTION SAMPLE OF THE SAME PRODUCT LOT. BASED ON THE RESULTS OF THE INVESTIGATION, ORGENICS WAS ABLE TO CONFIRM THE REPORTED COMPLAINT, HOWEVER A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. ONE POTENTIAL CAUSE IN THIS CASE COULD BE THE PRESENCE OF A SUBSTANCE WITHIN THE SAMPLE THAT COULD INFLUENCE THE TEST RESULT, SUCH AS TOXOPLASMA IGG, HUMAN ANTI-MOUSE ANTIBODIES, RHEUMATOID FACTOR, ELEVATED TRIGLYCERIDES, OR HERPES SIMPLEX VIRUS INFECTION. AS STATED IN THE WARNINGS SECTION OF THE PRODUCT INSERT FOR THE ALERE DETERMINE (B)(6) 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." ORGENICS HAS INITIATED A CORRECTIVE ACTION / PREVENTIVE ACTION (CAPA) INVESTIGATION (INTERNAL REFERENCE (B)(4)) TO FURTHER INVESTIGATE THE CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTION / PREVENTIVE ACTION (CAPA) INVESTIGATION (INTERNAL REFERENCE CAPA-(B)(4)) HAS BEEN COMPLETED FOR FURTHER INVESTIGATION OF REOCCURRING (B)(6) RESULTS WHEN TESTING LABOR AND DELIVERY SAMPLES. CAPA-(B)(4) ASSESSED THE SIGNIFICANCE OF THE (B)(6) 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL (B)(6) AB RESULT FOR A PERIPARTUM PT. CONFIRMATORY TESTING WAS PERFORMED BY EXTERNAL LABORATORY AND THE RESULT WAS (B)(6). THERE WERE NO ADVERSE PT OUTCOMES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533369 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD. 150602 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1