BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS SARS-COV-2 IGG

    MDR report key: 11275685 · Received February 3, 2021

    Report

    Report Number
    9680746-2021-00014
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 18, 2021
    Report Date
    February 3, 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 FULL IDENTIFIER IS (B)(6). THE ACCESS SARS-COV-2 IGG ASSAY WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF SYSTEM ISSUES AT THE TIME OF THE EVENT. SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO OTHER SYSTEM PERFORMANCE INFORMATION WAS PROVIDED. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    ON 22JAN2021 THE CUSTOMER REPORTED NON-REACTIVE COVID IGG RESULTS (ACCESS SARS-COV-2 IGG, PART NUMBER C58961 AND LOT NUMBER 971198) WERE GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE CUSTOMER STATED THAT THE PATIENT HAD A KNOWN CASE OF COVID-19 BUT DID NOT PROVIDE ANY ADDITIONAL DETAILS. THE CUSTOMER DID NOT INDICATE WHETHER THE RESULTS WERE RELEASED FROM THE LABORATORY. THE CUSTOMER DID NOT REPORT A CHANGE TO PATIENT CARE OF TREATMENT IN CONNECTION WITH THIS EVENT. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO OTHER INFORMATION SUCH AS CALIBRATION OR QUALITY CONTROL TEST RESULTS WERE PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. SAMPLE COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS SAMPLE TYPE, SAMPLE VOLUME COLLECTED, SAMPLE QUALITY, CENTRIFUGATION TIME AND SPEED, STORAGE TEMPERATURE AND OTHER INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170569 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