BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK

    MDR report key: 6985133 · Received October 27, 2017

    Report

    Report Number
    3007111389-2017-00169
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    August 6, 2017
    Report Date
    October 27, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MZF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS POSSIBLE THE (B)(4) RESULT IS DUE TO PRODUCT FAILURE IF THE SAMPLE CONTAINED DETECTABLE (B)(4) ANTIBODIES OR DUE TO INHERITED ASSAY LIMITATION IF THE SAMPLE WAS COLLECTED BEFORE SEROCONVERSION ((B)(4) FOR (B)(4) ANTIBODY, ONLY CONTAINING (B)(4) WITH OR WITHOUT (B)(4)). NO ADDITIONAL CONFIRMATORY TESTING WAS PERFORMED ON THE (B)(6) 2017 SAMPLE, AND IT IS NO LONGER AVAILABLE FOR ANY ADDITIONAL CONFIRMATORY TESTING. THE POSSIBILITY OF A (B)(4) DUE TO ASSAY FAILURE CANNOT BE COMPLETELY RULED OUT. HOWEVER, THE AVAILABLE INFORMATION ON THE TIMING AND RESULTS OF THE OTHER (B)(4) TESTS AND THE DISEASE PROGRESSION OF THIS DONOR STRONGLY SUGGEST THAT THE 06 AUGUST 2017 SAMPLE WAS WITHIN THE WINDOW PERIOD (THE PERIOD BETWEEN THE ONSET OF (B)(4) INFECTION AND BEING DETECTABLE BY THE ASSAY) OF THE VITROS HIV 1+2 ASSAY, A (B)(4) ASSAY. MOST LIKELY, THE (B)(4) RESULT OF THE (B)(6) 2017 SAMPLE WAS A TRUE ASSAY NEGATIVE RESULT FOR THE PRESENCE OF ANTIBODY TO (B)(4). BELOW ARE THE EVIDENCES: ¿ A (B)(4) TEST ON (B)(6) 2017 SAMPLE DETECTED VERY (B)(4), WHICH WAS AN INDICATION OF AN EARLY PHASE ACUTE (B)(4) INFECTION; PROBABLY RIGHT AFTER SEROCONVERSION AND AROUND 40-50 DAYS POST EXPOSURE (REFERENCE (B)(4) BELOW) . THE TIMING SUGGESTED THAT THE (B)(6) 2017 BLOOD WAS DRAWN WITHIN 1-2 WEEKS AFTER THE INFECTION AND BEFORE THE SEROCONVERSION, THUS TOO EARLY FOR THE VITROS HIV 1+2 ASSAY TO DETECT THE INFECTION. ¿ THE DONOR SOUGHT MEDICAL ATTENTION FOR STOMACH SYMPTOMS ONE WEEK AFTER THE BLOOD DONATION ((B)(6) 2017), ANOTHER WEEK LATER, THE SYMPTOMS LED THE SUSPICION OF (B)(4) INFECTION AND GOT THE DONOR TESTED ON (B)(6) 2017. SYMPTOMS FOR (B)(4) INFECTION USUALLY OCCUR WITHIN 2-4 WEEKS FOLLOWING EXPOSURE (REFERENCE (B)(4) BELOW). THIS PIECE OF INFORMATION ALSO SUGGESTS THE (B)(4) EXPOSURE/INFECTION PROBABLY HAPPENED WITHIN 1-2 WEEKS BEFORE THE (B)(6) 2017 BLOOD DRAW. THEREFORE, THE DONOR WAS BEFORE SEROCONVERSION ON (B)(6) 2017 AND WAS TOO EARLY FOR THE VITROS HIV 1+2 ASSAY TO DETECT THE INFECTION. ¿ ON (B)(6) 2017, THE PATIENT WAS TESTED (B)(4) USING THE (B)(4), AN ANTIBODY ASSAY FOR (B)(4) REPLACING THE (B)(4) CONFIRMATION. A PUBLICATION REPORTED THAT THE VITROS HIV 1+2 ASSAY COULD DETECT (B)(4) INFECTION 6 DAYS PRIOR TO A THE BIO-RAD MULTISPOT ASSAY (REFERENCE (B)(4) BELOW), SINCE THE VITROS HIV 1+2 (B)(4) RESULT AND (B)(4) RESULT IN THIS CASE WERE 17 DAYS APART, THE (B)(6) 2017 SAMPLE LIKELY FALLS IN THE WINDOW PERIOD BETWEEN THE MOMENT OF INFECTION AND SEROCONVERSION AND THEREFORE, BEYOND THE VITROS HIV 1+2 TEST DETECTION CAPABILITY. ¿ NO ABNORMITIES WERE DETECTED IN THE QUALITY CONTROL TEST RECORD OF THE VITROS HIV 1+2 ASSAY OR THE ANALYZER USED IN THIS BLOOD BANK LAB AROUND (B)(6) 2017. BASED ON THE ABOVE INFORMATION, IT IS VERY LIKELY THAT THE (B)(6) 2017 BLOOD DRAW WAS COLLECTED SOMETIME DURING THE WINDOW PERIOD OF APPROXIMATELY 2 WEEKS FROM INFECTION ¿ PER FIG (B)(4), THEREFORE BEYOND VITROS HIV 1+2 ASSAY DETECTION CAPABILITY. REFERENCES: (B)(4). NO EVIDENCE INDICATES THIS WAS DUE TO A MALFUNCTION OF THE VITROS HIV 1+2 ASSAY OR THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE LABELING FOR VITROS ANTI-HIV 1+2 REAGENT INTENDED FOR USE IN THE UNITED STATES INCLUDES THE FOLLOWING WARNING: ¿THIS ASSAY HAS NOT BEEN FDA CLEARED, LICENSED OR APPROVED FOR THE SCREENING OF BLOOD OR PLASMA DONORS.¿

    Description of Event or Problem · 1

    ON (B)(6) 2017, A BLOOD DONOR WAS TESTED WITH THE VITROS HIV 1+2 ASSAY AT A BLOOD BANK IN (B)(6) USING THE VITROS HIV 1+2 ASSAY AND PRODUCED A (B)(6) TEST RESULT ((B)(6)). THE BLOOD OF THIS DONOR WAS TRANSFUSED TO TWO PEDIATRIC PATIENTS (A (B)(6) BOY AND A (B)(6) GIRL) ON (B)(6), RESPECTIVELY. ONE WEEK AFTER THE DONATION, THE DONOR VISITED A HEALTH CARE PROVIDER FOR STOMACH SYMPTOMS AND TREATMENT WAS INITIATED FOR SALMONELLOSIS. THIS HEALTH CARE PROVIDER IS (B)(6), A GOVERNMENT INSTITUTION FOR HEALTH. AFTER THE DONOR¿S SYMPTOMS DID NOT IMPROVE, ON (B)(6) 2017 (17 DAYS AFTER THE (B)(6) TEST USING THE VITROS HIV 1+2 ASSAY), A BLOOD SAMPLE WAS DRAWN AND PRODUCED A (B)(6) RESULT USING THE (B)(6). ON (B)(6) 2017, THE (B)(6) RESULT WAS REPORTED TO THE DONOR. ON (B)(6) 2017, THE DONOR INFORMED THE BLOOD BANK OF THE (B)(6) RESULT. ON (B)(6) 2017, SAMPLES WERE DRAWN FROM THE DONOR AT THE BLOOD BANK AND TESTED WITH THE VITROS HIV 1+2 ASSAY. THE TEST RESULTS FOR BOTH SAMPLES WERE (B)(6), (B)(6), RESPECTIVELY. (B)(6) INFECTION WAS ALSO CONFIRMED AT A REFERENCE LAB ((B)(6)) USING AN (B)(6). THE TWO PEDIATRIC BLOOD RECIPIENTS WERE CONFIRMED TO BE INFECTED WITH (B)(6) AND ARE CURRENTLY BEING TREATED WITH (B)(6) THERAPIES. IT WAS DETERMINED THE (B)(6) 2017 BLOOD DONATION CONTAINED (B)(6) AND WAS INFECTIOUS. THIS CASE IS CONSIDERED AS A SERIOUS ADVERSE EVENT WITH SERIOUS LONG-TERM HEALTH IMPACT TO THESE TWO PEDIATRIC BLOOD RECIPIENTS. BOTH PEDIATRIC PATIENTS WILL LIKELY TO BE ON LIFE-LONG (B)(6) THERAPIES FOR (B)(6) MANAGEMENT. WITH THE CURRENT ADVANCEMENT OF THE (B)(6) MEDICATIONS, IT IS VERY LIKELY THE TWO PATIENTS WILL KEEP (B)(6) UNDER CONTROL AND LIVE THROUGH A NORMAL LIFE EXPECTANCY, HOWEVER, THERE IS NO CURE FOR (B)(6) AND THERE ARE POSSIBILITIES THE PATIENTS MAY DEVELOP COMPLICATIONS TO THE (B)(6) THERAPIES OR (B)(6) DUE TO UNCONTROLLED (B)(6) INFECTION. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764775 VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HIV 1+2 REAGENT PACK IN-VITRO DIAGNOSTIC MZF ORTHO-CLINICAL DIAGNOSTICS 3600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other