BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG

    MDR report key: 11956468 · Received June 8, 2021

    Report

    Report Number
    9680746-2021-00043
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 8, 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

    (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 ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. LOCAL SUPPORT AND MEDICAL SCIENTIFIC AFFAIRS DISCUSSED DIFFERENCES BETWEEN ASSAYS WITH THE CUSTOMER AS VALUES OBTAINED WITH DIFFERENT ASSAY METHODS SHOULD NOT BE USED INTERCHANGEABLY AND DIFFERENCES BETWEEN METHODS ARE EXPECTED. IN CONCLUSION, AN ASSIGNABLE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. 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 NON-REACTIVE SARS-COV-2 IGG (ACCESS SARS-COV-2 IGG ASSAY, PART NUMBER C58961, LOT NUMBER 971198) RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER 81600N AND SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED OBTAINING POSITIVE RESULTS IN AN ALTERNATE LABORATORY (NO FURTHER INFORMATION WAS PROVIDED). ADDITIONAL INFORMATION REGARDING THE IMPACTED SAMPLES WAS NOT PROVIDED IN THIS EVENT. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. THE EXPIRATION DATE OF THE REAGENT LOT PROVIDED BY CUSTOMER IS 23JAN2021. LOCAL SUPPORT DISCUSSED DIFFERENCES IN METHODS WITH THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853109 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