BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALERE DETERMINE HIV-1/2 AG/AB COMBO

    MDR report key: 4925820 · Received July 17, 2015

    Report

    Report Number
    3008754095-2015-00002
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 16, 2015
    Manufacturer
    ORGENICS LTD.
    Product Code
    MZF
    PMA / PMN Number
    120037/0
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVOLVED A REPORTED (B)(6), AG LINE RESULT. THE SAMPLE WAS TESTED NON REACTIVE BY (B)(6) AND BY ALERE DETERMINE (B)(4) FROM DIFFERENT LOT. AN INVESTIGATION HAS BEEN CONDUCTED BY ORGENICS WITH THE FOLLOWING ACTIVITIES AND RESULTS: THE ASSAY PERFORMANCE WAS ASSESSED BY TESTING A KIT LOT # 150507 FROM QC RETENTION. THE KIT PERFORMED ACCORDINGLY WITH QC SPECIFICATION. HISTORY RECORD OF RELEASE TESTING (QC) DATA AND BATCH RECORDS FOR LOT #150507 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. 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 ((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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL FALSE POSITIVE (B)(6) RESULT FOR A PERIPARTUM PT. CUSTOMER REPORTED THAT THE PT UNDERWENT A CAESAREAN (C) - SECTION. THERE WERE NO REPORTED COMPLICATIONS DUE TO THE C-SECTION. PER THE DETERMINE COMBO LABELING, ALL POSITIVE RESULTS REQUIRE VERIFICATION. ACCORDING TO THE CUSTOMER REPORTING THE EVENT, CONFIRMATORY TESTING BY EXTERNAL LABORATORY WAS NOT PERFORMED UNTIL AFTER THE C-SECTION; THE LAB RESULT WAS REPORTEDLY NEGATIVE. THE PERIPARTUM PT (NOT THE INFANT) RECEIVED PROPHYLACTIC MEDICATIONS. THEREFORE THIS REPORT CONCERNS ONLY ONE PT AND EXCLUDES THE INFANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466364 ALERE DETERMINE HIV-1/2 AG/AB COMBO IVD FOR HIV AG/AB MZF ORGENICS LTD. 150507

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| O