BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I CYCLOSPORINE REAGENT KIT

    MDR report key: 11891771 · Received May 27, 2021

    Report

    Report Number
    3008344661-2021-00112
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    March 13, 2021
    Report Date
    August 2, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    MKW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR POTENTIAL DEPRESSED ALINITY I CYCLOSPORINE VALUES INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF THE COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DETERMINED NO RELATED TREND FOR THE LOT. IN HOUSE TESTING USING A RETAINED KIT OF THE COMPLAINT LOT 21642FN00 WAS PERFORMED. ALL SPECIFICATIONS WERE MET INDICATING THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW OF LOT 21642FN00 DID NOT SHOW ANY NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. PER PRODUCT LABELING THERAPEUTIC RANGES VARY ACCORDING TO THE COMMERCIAL TEST USED, AND THEREFORE SHOULD BE ESTABLISHED FOR EACH COMMERCIAL TEST. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY DUE TO DIFFERENCES IN ASSAY METHODS AND CROSS-REACTIVITY WITH METABOLITES, NOR SHOULD CORRECTION FACTORS BE APPLIED. THEREFORE, CONSISTENT USE OF ONE ASSAY FOR INDIVIDUAL PATIENTS IS RECOMMENDED. WHEN CHANGING CYCLOSPORINE ASSAY METHODS, INCLUDING BETWEEN ABBOTT ASSAYS, IN THE COURSE OF MONITORING A PATIENT, ADDITIONAL SEQUENTIAL TESTING SHOULD BE CARRIED OUT TO CONFIRM BASELINE VALUES. BASED ON THE INVESTIGATION ALINITY I CYCLOSPORINE REAGENT LOT 21642FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I CYCLOSPORINE REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 9P39 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L75. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSELY DEPRESSED ALINITY I CYCLOSPORINE RESULTS ON SEVERAL PATIENTS WHEN COMPARED TO THE RESULTS OBTAINED PREVIOUSLY WITH THE ARCHITECT CYCLOSPORINE ASSAY. THE CUSTOMER WAS ABLE TO PROVIDE 1 PATIENT EXAMPLE: ON (B)(6) 2021 (PATIENT WITH A MEDICATION REGIMEN OF 75/0/75) ARCHITECT CYCLOSPORINE RESULT = 283 NG/ML. ON (B)(6) 2021 (SAME PATIENT WITH A MEDICATION REGIMEN OF 75/0/50) ALINTIY I CYCLOSPORINE RESULT = 79.80 NG/ML. ON (B)(6) 2021 (SAME PATIENT WITH A MEDICATION REGIMEN OF 75/0/75) ALINITY I CYCLOSPORINE = 133.90 NG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792350 ALINITY I CYCLOSPORINE REAGENT KIT CYCLOSPORINE MKW ABBOTT IRELAND 21642FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, AI20544