BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS IL-6 REAGENT

    MDR report key: 11673519 · Received April 15, 2021

    Report

    Report Number
    2122870-2021-00046
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    QLC
    UDI-DI
    15099590201852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL IDENTIFIER IS (B)(4). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS IL-6 ASSAY WAS NOT RETURNED FOR EVALUATION. THERE WERE NO REPORTS OF SYSTEM ISSUES AT THE TIME OF THE EVENT. NO OTHER ASSAY ISSUES WERE REPORTED. NO HARDWARE ERRORS OR FLAGS WERE REPORTED IN CONJUNCTION WITH THE EVENT. SYSTEM CHECK WAS PASSING AT THE TIME OF THE EVENT. IL-6 CALIBRATION WAS PERFORMED ON (B)(6) 2020 WITH IL-6 REAGENT LOT 922163. THIS CALIBRATION WAS 9 MONTHS OLD AT THE TIME OF THE EVENT; IT HAD EXPIRED ON 15JULY 2020. THE CUSTOMER WAS NOT PERFORMING QUALITY CONTROL TESTING AT THE TIME OF THE EVENT. ADDITIONALLY, THE CUSTOMER WAS USING EDTA PLASMA AS A SPECIMEN TYPE; PER THE ACCESS IL-6 INSTRUCTIONS FOR USE (PART NUMBER C72294 A), PREFERRED SPECIMEN TYPES ARE SERUM AND PLASMA (HEPARIN). IN CONCLUSION, ALTHOUGH EXPIRED CALIBRATION MAY HAVE CONTRIBUTED TO THE EVENT, A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST REAGENT OR INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED ERRATIC IL-6 (ACCESS IL-6 ASSAY, PART NUMBER A16369, LOT NUMBER 922163) PATIENT RESULTS WERE GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER A65531 AND SERIAL NUMBER(B)(4))) FOR ONE PATIENT. THE INITIAL RESULT, OBTAINED ON (B)(6) 2021 USING A SERUM SAMPLE FROM THE PATIENT, WAS 433.25 PG/ML (21:19); A EDTA PLASMA SAMPLE OBTAINED FROM THE SAME PATIENT WAS TESTED ON THE SAME ACCESS 2 ANALYZER ON (B)(6) 2021 AND A RESULT OF 3.39 PG/ML (22:35) WAS OBTAINED. NO AFFECT TO PATIENTS OR END-USERS HAS BEEN REPORTED IN CONNECTION WITH THIS EVENT. THE CUSTOMER INDICATED THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. DATA PROVIDED SHOWED SYSTEM CHECK PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THAT DATA ALSO INCLUDED A IL-6 CALIBRATION WHICH HAD BEEN PERFORMED ON (B)(6) 2020 WITH IL-6 REAGENT LOT 922163. THIS CALIBRATION WAS 9 MONTHS OLD AT THE TIME OF THE EVENT; IT HAD EXPIRED ON 15JULY 2020. THE CUSTOMER WAS NOT PERFORMING QUALITY CONTROL TESTING AT THE TIME OF THE EVENT. THERE WERE NO ISSUES WITH SAMPLE INTEGRITY REPORTED BY THE CUSTOMER. SAMPLE INFORMATION INCLUDING COLLECTION, HANDLING AND PROCESSING INFORMATION SUCH AS STORAGE AND OTHER SAMPLE RELATED INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569931 ACCESS IL-6 REAGENT IMMUNOASSAY METHOD, INTERLEUKIN QLC BECKMAN COULTER 922163 15099590201852

    Patients

    Seq Age Sex Outcome Treatment
    1