BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 19358795 · Received May 21, 2024

    Report

    Report Number
    3005094123-2024-00268
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 5, 2024
    Report Date
    June 10, 2024
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740160630
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. ADDITIONALLY, A BATCH HISTORY RECORD REVIEW WAS COMPLETED. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. A TICKET SEARCH BY LOT IDENTIFIED SLIGHTLY HIGHER COMPLAINT ACTIVITY; HOWEVER, NO RELATED TRENDS WERE IDENTIFIED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY RELATED NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH LOT NUMBER 58245UD00 AND THE COMPLAINT ISSUE. THE OVERALL PERFORMANCE OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I WAS REVIEWED USING FILED DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE REVIEW SHOWS THAT THE MEDIAN PATIENT RESULTS FOR THE COMPLAINT LOT IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH HISTORICAL LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR THE LOT. A BATCH HISTORY RECORD (BHR) REVIEW OF RELEASE DATA HAS BEEN PERFORMED FOR THE COMPLAINT LOTS. THE VALUES OF DIFFERENT LEVELS OF CONTROLS AND PANELS TESTED WITH REAGENT LOT 58245UD00 WERE WELL WITHIN THE SPECIFICATIONS. THE DIFFERENT LEVELS OF CONTROLS WERE WELL WITHIN THEIR SPECIFICATION RANGES USING THE CALIBRATOR LOT 48687UD00. NO UPSHIFT WAS IDENTIFIED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER¿S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT LOT 58245UD00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.  THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P13, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04Z21.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR A 56 YEAR OLD MALE PATIENT WITH A HISTORY OF ELEVATED TROPONIN I RESULTS. THE CUSTOMER INDICATED THAT THE PATIENT PREVIOUSLY HAD TWO CORONARY ARTERY ANGIOGRAPHY¿S (CAG). THE FIRST WAS NORMAL, HOWEVER THE SECOND WAS ABNORMAL AND THE PATIENT HAD A CORONARY STENT IMPLANTED. OVER THE NEXT THREE MONTHS THE PATIENT¿S TROPONIN RESULTS REMAINED HIGH. THERE IS NO INFORMATION AVAILABLE ON WHEN THE PATIENT HAD THE CAGS COMPLETED. THE PATIENT WAS RECENTLY SEEN AT ANOTHER HOSPITAL DUE TO CHEST PAIN AND HAD A POSITIVE TROPONIN RESULT ON AN ALINITY INSTRUMENT (NO SPECIFIC VALUES WERE AVAILABLE). THE DOCTOR ORDERED AN MRI THAT FOUND NO SIGNS OF A MYOCARDIAL INFARCTION. THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL ((B)(6) HOSPITAL, CURRENT CUSTOMER) WHERE THE TROPONIN RESULTS REMAINED ELEVATED. ON (B)(6) 2024 SAMPLE ID (B)(6) INITIAL RESULT = 244.4 NG/L (REFERENCE RANGE <34.2 NG/L), REPEAT RESULT ON ROCHE PLATFORM = 9.41 NG/L (REFERENCE RANGE <16.8 NG/L) DUE TO THE ELEVATED RESULTS THE PATIENT RECEIVED A CAG AND MRI THAT HAD NORMAL RESULTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR A 56 YEAR OLD MALE PATIENT WITH A HISTORY OF ELEVATED TROPONIN I RESULTS. THE CUSTOMER INDICATED THAT THE PATIENT PREVIOUSLY HAD TWO CORONARY ARTERY ANGIOGRAPHY¿S (CAG). THE FIRST WAS NORMAL, HOWEVER THE SECOND WAS ABNORMAL AND THE PATIENT HAD A CORONARY STENT IMPLANTED. OVER THE NEXT THREE MONTHS THE PATIENT¿S TROPONIN RESULTS REMAINED HIGH. THERE IS NO INFORMATION AVAILABLE ON WHEN THE PATIENT HAD THE CAGS COMPLETED. THE PATIENT WAS RECENTLY SEEN AT ANOTHER HOSPITAL DUE TO CHEST PAIN AND HAD A POSITIVE TROPONIN RESULT ON AN ALINITY INSTRUMENT (NO SPECIFIC VALUES WERE AVAILABLE). THE DOCTOR ORDERED AN MRI THAT FOUND NO SIGNS OF A MYOCARDIAL INFARCTION. THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL (B)(6) HOSPITAL, CURRENT CUSTOMER) WHERE THE TROPONIN RESULTS REMAINED ELEVATED. (B)(6) 2024 SAMPLE ID (B)(6); INITIAL RESULT = 244.4 NG/L (REFERENCE RANGE <34.2 NG/L), REPEAT RESULT ON ROCHE PLATFORM = 9.41 NG/L (REFERENCE RANGE <16.8 NG/L) DUE TO THE ELEVATED RESULTS THE PATIENT RECEIVED A CAG AND MRI THAT HAD NORMAL RESULTS. NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616891 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 58245UD00 00380740160630

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Disability ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)