BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 5008689 · Received August 13, 2015

    Report

    Report Number
    3008754095-2015-00008
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    April 12, 2014
    Report Date
    July 2, 2015
    Manufacturer
    ORGENICS LTD.
    Product Code
    MZF
    PMA / PMN Number
    120037/0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVES REPORTED A FALSE POSITIVE RESULT ON THE AB AND AG LINES. IT HAS BEEN REPORTED THAT THE PATIENT SAMPLE WAS TESTED NON-REACTIVE ON CONFIRMATORY TEST, THE METHOD OF WHICH IS UNKNOWN. AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING A KIT LOT # 140216 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT #140216 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, A DEFINITIVE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED.

    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.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535768 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD. 140216

    Patients

    Seq Age Sex Outcome Treatment
    1