BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGG II QUANT REAGENT KIT

    MDR report key: 12014187 · Received June 16, 2021

    Report

    Report Number
    3008344661-2021-00121
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 30, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06S61-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6S61-20/-30.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY NEGATIVE ALINITY SARS-COV-2 IGG II QUANT. RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. SENSITIVITY AND SPECIFICITY TESTING WERE DONE USING AN IN-HOUSE RETAINED KIT OF LOT 27525FN00 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. TESTING WAS NOT PERFORMED FOR LOT 27529FN00 AS LOTS 27525FN00 AND 27529FN00 CONTAIN THE SAME BULK MATERIALS. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 27525FN00 AND 27529FN00 DID NOT SHOW ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN THIS CASE, THE SEROLOGICAL TESTING TIMELINE IS UNKNOWN. NO VACCINATION DATES OR SEROLOGICAL TEST DATES WERE PROVIDED. IN ADDITION, NO PATIENT INFORMATION WAS PROVIDED. PER PRODUCT LABELING, IMMUNOCOMPROMISED PATIENTS WHO HAVE COVID-19 MAY HAVE A DELAYED ANTIBODY RESPONSE AND PRODUCE LEVELS OF ANTIBODY WHICH MAY NOT BE DETECTED AS POSITIVE BY THE ASSAY. IN ADDITION, THE PERSISTENCE OF A SARS-COV-2 IMMUNE RESPONSE HAS NOT BEEN FULLY ESTABLISHED. NEGATIVE RESULTS MAY BE OBSERVED DUE TO A DECLINE IN ANTIBODY TITER OVER TIME. RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., SYMPTOMS, RESULTS OF OTHER TESTS, AND CLINICAL IMPRESSIONS. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY SARS-COV-2 IGG II QUANT REAGENT LOTS 27525FN00 AND 27529FN00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I SARS-COV-2 IGG II QUANT. RESULTS ON MULTIPLE HEALTHCARE WORKERS WHO HAVE BEEN VACCINATED WITH 2 DOSES OF THE PFIZER VACCINE. THE CUSTOMER IS AWARE THAT THE PFIZER-BIONTECH VACCINE WAS 95% EFFECTIVE AT PREVENTING LABORATORY-CONFIRMED COVID-19 ILLNESS IN PEOPLE WITHOUT EVIDENCE OF PREVIOUS INFECTION. THE PATIENT SAMPLES GENERATED A SARS-COV IGG II QUANT. RESULTS OF 0.0 AU/ML (< 50.0 AU/ML IS NEGATIVE). ADDITIONAL INFORMATION PROVIDED ON 03JUN2021, THAT THE CUSTOMER IS SEEING AN OVERALL PERCENTAGE OF PATIENT SARS-COV-2 IGG II QUANT. RESULTS OF 0.0 AU/ML IS 4.68% (64 OUT OF 1365 PATIENT RESULTS). A REVIEW OF OTHER (B)(6) CUSTOMERS GIVES AN OVERALL PERCENTAGE OF 10.4 % OF 0.0 AU/ML PATIENT RESULTS (IN THIS CASE NO INFO AVAILABLE ABOUT VACCINATION STATUS). NO OTHER SPECIFIC INFORMATION WAS PROVIDED BY THE CUSTOMER. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905015 SARS-COV-2 IGG II QUANT REAGENT KIT SARS-COV-2 LGG QKO ABBOTT IRELAND 27525FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALI COV2 G II 1000T OUS, 06S61-32, (B)(4)| ALI COV2 G II 1000T OUS, 06S61-32, (B)(4)| ALNTY I PROCESSING MODU, 03R65-01, (B)(4)| ALNTY I PROCESSING MODU, 03R65-01, (B)(4)