BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT SIROLIMUS

    MDR report key: 24269861 · Received February 5, 2026

    Report

    Report Number
    3008344661-2026-00029
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 28, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    NRP
    UDI-DI
    00380740179502
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT INVESTIGATION WAS CONDUCTED FOR THE ARCHITECT SIROLIMUS REAGENT LOT 76675FP01TO ASSESS THE CUSTOMER OBSERVATION FOR FALSE ELEVATED RESULTS FOR MULTIPLE PATIENTS. PER THE PACKAGE INSERT, IT'S NOT ALLOWED TO USE THE REAGENT IF THE MICROPARTICLES DO NOT RESUSPEND. REVIEW OF TRACKING AND TRENDING BY LIST NUMBER AND BY COMPLAINT LOT DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR IMPACTED LOT. THE REVIEW WAS PERFORMED ON LOT 76675FP00 AS IT IS A SISTER LOT TO THE LIKELY CAUSE LOT 76675FP01. THIS FURTHER INVESTIGATION REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES OBTAINED WITH THE COMPLAINT LOT 76675FP01 ARE WITHIN ESTABLISHED LIMITS AND THUS COMPARABLE TO THE HISTORICAL LOT PERFORMANCE, WHICH CONFIRMS NO SYSTEMIC ISSUE FOR THE LOT. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES WITH LOT 76675FP01. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SIROLIMUS REAGENT LOT 76675FP01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 01L76-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01L76, WITH 510K NUMBER K070822. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT SIROLIMUS ON 6 PATIENTS AFTER OPENING A NEW BOTTLE OF REAGENT WITH (B)(6). RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID INITIAL RESULTS (B)(6) REPEAT RESULTS (B)(6) REPEAT RESULTS (B)(6): SID1 19.74 NG/ML, 20.59 NG/ML, 4.49 NG/ML SID 2 22.23 NG/ML, 20.07 NG/ML, 5.26 NG/ML, SID 3 17.27 NG/ML, 18.16 NG/ML, 3.36 NG/ML, SID 4 20.47 NG/ML, 19.35 NG/ML, 4.91 NG/ML, SID 5 17.08 NG/ML, 17.42 NG/ML, 3.42 NG/ML, SID 6 19.95 NG/ML, 22.5 NG/ML, 4.83 NG/ML.. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE ELEVATED ARCHITECT SIROLIMUS ON 6 PATIENTS AFTER OPENING A NEW BOTTLE OF REAGENT WITH SN (B)(6). RESULTS WERE NOT REPORTED TO MEDICAL PROVIDER. THE FOLLOWING DATA WAS PROVIDED. SID INITIAL RESULTS (SN (B)(6) REPEAT RESULTS (SN (B)(6) REPEAT RESULTS (SN (B)(6). SID1 19.74 NG/ML, 20.59 NG/ML, 4.49 NG/ML SID 2 22.23 NG/ML, 20.07 NG/ML, 5.26 NG/ML SID 3 17.27 NG/ML, 18.16 NG/ML, 3.36 NG/ML SID 4 20.47 NG/ML, 19.35 NG/ML, 4.91 NG/ML SID 5 17.08 NG/ML, 17.42 NG/ML, 3.42 NG/ML SID 6 19.95 NG/ML, 22.5 NG/ML, 4.83 NG/ML. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285770 ARCHITECT SIROLIMUS SIROLIMUS TEST SYSTEM NRP ABBOTT IRELAND DIAGNOSTICS DIVISION 76675FP01 00380740179502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2000SR INST, 03M74-02, (B)(6).| ARC I2000SR INST, 03M74-02, (B)(6).