BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 5269952 · Received December 7, 2015

    Report

    Report Number
    3008754095-2015-00021
    Event Type
    Malfunction
    Date Received
    December 7, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 25, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    CORRECTIVE ACTION / PREVENTIVE ACTION (CAPA) INVESTIGATION ((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 (B)(6) 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

    THIS COMPLAINT INVOLVED A REPORTED FALSE POSITIVE RESULT OF THE AG LINE. FOLLOWING THE FALSE POSITIVE AG RESULT, CONFIRMATORY TEST WAS PERFORMED WITH A NON-REACTIVE RESULTS. CONFIRMATORY METHOD WAS NOT PROVIDED. AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING A KIT LOT # 150623 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT #150623 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 NOT ABLE TO BE REPLICATED, THE OBTAINED RESULT WAS NEGATIVE. BASED ON THE RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. ORGENICS HAS INITIATED A CORRECTIVE ACTION / PREVENTIVE ACTION (CAPA) INVESTIGATION (INTERNAL REFERENCE (B)(4)) TO FURTHER INVESTIGATE THE CAUSE OF THIS EVENT.

    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
    803071 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD 150623 07290015003735

    Patients

    Seq Age Sex Outcome Treatment
    1