BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 17256135 · Received July 5, 2023

    Report

    Report Number
    3005094123-2023-00167
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 25, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 8P13 HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, FIELD DATA REVIEW, AND IN HOUSE TESTING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY RELATED TRENDS FOR THE PRODUCT FOR THE ISSUE. DEVICE HISTORY RECORD REVIEW ON LOT 49083UD00 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 49083UD00 AND THE COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT STAT HIGH SENSITIVE TROPONIN-I ASSAY USING WORLDWIDE DATA. THE MEDIAN POPULATION RESULT FOR COMPLAINT LOT 49083UD00 ARE WITHIN ESTABLISHED LIMITS, INDICATING THAT THE LOT(S) ARE PERFORMING ACCEPTABLY IN THE FIELD. IN-HOUSE ACCURACY TESTING WAS COMPLETED WITH COMPLAINT LOT NUMBER 49083UD00. ALL SPECIFICATIONS WERE MET INDICATING THAT LOT 49083UD00 IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I FOR LOT NUMBER 49083UD00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A 48 YEAR OLD MALE PATIENT PRESENTING WITH CHEST PAIN. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023, SID (B)(6) , INITIAL RESULT = 93.4 PG/ML. THE PATIENT WAS TRANSFERRED TO THE ICU AND STARTED ON AN ANTI-ISCHEMIC REGIMEN OF INTRAVENOUS NITRATE AND POTASSIUM. ADDITIONALLY, THE FOLLOWING MEDICATION WAS GIVEN: LOSARTAN POTASSIUM (50 MG EVERY 12 HOURS). CLOPIDOGREL (75 MG EVERY 24 HOURS). LOW MOLECULAR WEIGHT HEPARIN (60 MG FOR 24 HOURS). ACETYLSALICYLIC ACID (100 MG / 24 HOURS). A NEW SAMPLE WAS COLLECTED AND GENERATED A NEGATIVE RESULT OF 8.9 PG/ML. THE ORIGINAL SAMPLE WAS REPEATED AND GENERATED A NEGATIVE RESULT OF 11.2 PG/ML. THE ORIGINAL SAMPLE WAS ALSO RUN AT ANOTHER LABORATORY AND GENERATED A NEGATIVE RESULT OF 11.7 PG/ML. THE PATIENT¿S FINAL DIAGNOSIS WAS HIGH-RISK UNSTABLE ANGINA-TYPE ACUTE CORONARY SYNDROME. SCORE GRACE 67 KK I/IV. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT FOR A 48 YEAR OLD MALE PATIENT PRESENTING WITH CHEST PAIN. THE FOLLOWING DATA WAS PROVIDED: 12JUN2023 SID (B)(6) INITIAL RESULT = 93.4 PG/ML THE PATIENT WAS TRANSFERRED TO THE ICU AND STARTED ON AN ANTI-ISCHEMIC REGIMEN OF INTRAVENOUS NITRATE AND POTASSIUM. ADDITIONALLY, THE FOLLOWING MEDICATION WAS GIVEN: LOSARTAN POTASSIUM (50 MG EVERY 12 HOURS). CLOPIDOGREL (75 MG EVERY 24 HOURS). LOW MOLECULAR WEIGHT HEPARIN (60 MG FOR 24 HOURS). ACETYLSALICYLIC ACID (100 MG / 24 HOURS). A NEW SAMPLE WAS COLLECTED AND GENERATED A NEGATIVE RESULT OF 8.9 PG/ML. THE ORIGINAL SAMPLE WAS REPEATED AND GENERATED A NEGATIVE RESULT OF 11.2 PG/ML. THE ORIGINAL SAMPLE WAS ALSO RUN AT ANOTHER LABORATORY AND GENERATED A NEGATIVE RESULT OF 11.7 PG/ML. THE PATIENT¿S FINAL DIAGNOSIS WAS HIGH-RISK UNSTABLE ANGINA-TYPE ACUTE CORONARY SYNDROME. SCORE GRACE 67 KK I/IV. NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417717 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 49083UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male ALNTY I PROCESSING MODU, 03R65-01, AI02312| ALNTY I PROCESSING MODU, 03R65-01, AI02312