BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG

    MDR report key: 11378035 · Received February 25, 2021

    Report

    Report Number
    9680746-2021-00020
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 9, 2021
    Report Date
    February 25, 2021
    Manufacturer
    CLARE DISCRETE MFG IO
    Product Code
    QKO
    UDI-DI
    15099590738648
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FILL PATIENT IDENTIFIER IS CASE-(B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS SARS-COV-2 IGG REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND OBSERVED THAT THE CALIBRATION CURVE, THE REAGENT PACK AND SUBSTRATE WERE EXPIRED AND SUGGESTED TO THE CUSTOMER TO NOT USE EXPIRED MATERIALS. ADDITIONALLY, NO MANUFACTURER GUARANTEES BOTH A SPECIFICITY AND SENSITIVITY OF 100%. DIFFERENCES IN EACH INDIVIDUAL ASSAY ARE EXPECTED. IN CONCLUSION, THE EXACT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. DIFFERENCES BETWEEN METHODS ARE EXPECTED. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2021 THE CUSTOMER REPORTED ONE NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971198) RESULT WAS GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE PATIENT SAMPLE RESULT WAS QUESTIONED AS THE PATIENT HAD TAKEN COVISHIELD VACCINE 2 MONTHS BEFORE. CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY TO BE RETESTED WITH THE DIASORIN METHODOLOGY. THE NON-REACTIVE ACCESS SARS-COV-2 IGG RESULT OF 0.20 S/CO OBTAINED ON (B)(6) 2021 WAS DISCORDANT WITH THE REACTIVE DIASORIN RESULT OF 31 AU/ML (DATA NOT PROVIDED). NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION RUN ON (B)(6) 2020 WAS EXPIRED AT THE TIME OF THE EVENT. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK FAILED THE SUBSTRATE RATIO AND UNWASHED PORTION ON (B)(6) 2021, WITH EXS FLAGS MEANING THAT THE SUBSTRATE WAS EXPIRED. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, CENTRIFUGATION, STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277962 ACCESS SARS-COV-2 IGG IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS QKO CLARE DISCRETE MFG IO 971198 15099590738648

    Patients

    Seq Age Sex Outcome Treatment
    1