BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 19713494 · Received July 10, 2024

    Report

    Report Number
    3005094123-2024-00371
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    April 19, 2024
    Report Date
    August 28, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740118075
    PMA / PMN Number
    K191595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT NUMBER AND COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR THE LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. IN THIS CASE, THE SAMPLE WAS TREATED WITH HETEROPHILIC ANTIBODY BLOCKING TUBES WITH RESULTS RETURNED BELOW THE ASSAY CUTOFF. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TICKET TRENDING DID NOT IDENTIFY ANY RELATED TRENDS. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE LOT NUMBER AND COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING WORLDWIDE DATA. THE LOT IS UNKNOWN IN THIS CASE, HOWEVER REVIEW OF THE WITHIN DATE LOTS WITH AT LEAST 10000 PATIENT RESULTS SHOW THAT ALL MEDIAN VALUES ARE WITHIN ESTABLISHED LIMITS INDICATING THE LOTS ARE COMPARABLE AND PERFORMING ACCEPTABLY IN THE FIELD. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. IN THIS CASE, THE SAMPLE WAS TREATED WITH HETEROPHILIC ANTIBODY BLOCKING TUBES WITH RESULTS RETURNED BELOW THE ASSAY CUTOFF. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE. A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 03P25 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 02R98.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE PHYSICIAN QUESTIONED FALSELY ELEVATED TROPONIN RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 65.6 NG/ML, (B)(6) 2024 85.5 NG/ML, (B)(6) 2024 225 NG/ML, (B)(6) 2024 217.4 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: AFTER MEASURING WITH SCANTIBODIES TUBE, THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS ARE <4 PG/ML.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE PHYSICIAN QUESTIONED FALSELY ELEVATED TROPONIN RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 65.6 NG/ML; (B)(6) 2024 85.5 NG/ML; (B)(6) 2024 225 NG/ML; (B)(6) 2024 217.4 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UPDATE: AFTER MEASURING WITH SCANTIBODIES TUBE, THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS ARE <4 PG/ML.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THAT THE PHYSICIAN QUESTIONED FALSELY ELEVATED TROPONIN RESULTS. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) 2024 65.6 NG/ML. (B)(6) 2024 85.5 NG/ML. (B)(6) 2024 225 NG/ML. (B)(6) 2024 217.4 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144580 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 64186UD00 00380740118075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I1000SR MOD, 01L86-01, (B)(6).| ARC I1000SR MOD, 01L86-01, (B)(6).| ARC I1000SR MOD, 01L86-01, (B)(6).