BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

    MDR report key: 22859814 · Received August 21, 2025

    Report

    Report Number
    3005094123-2025-00407
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    August 10, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION IN SECTION B5: TYPOGRAPHICAL ERROR: RESULTS ARE FOR ONE PATIENT AND NOT MULTIPLE PATIENTS. THE COMPLAINT INVESTIGATION FOR FALSELY DEPRESSED ALINITY I STAT HIGH SENSITIVITY 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. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I STAT HIGH SENSITIVE TROPONIN-I ASSAY DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ADDITIONALLY, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR REAGENT LOT 75636UD00. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER. IN HOUSE ACCURACY TESTING WAS COMPLETED FOR THE COMPLAINT LOT 75636UD00 USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. THE OVERALL PERFORMANCE OF ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENTS WAS REVIEWED USING DATA GATHERED FROM CUSTOMERS WORLDWIDE. THE PATIENT MEDIAN VALUES FOR LOTS 75633UD00 AND 75638UD00 (WHICH CONTAIN THE SAME BULK MATERIAL AS LOT 75636UD00) ARE WITHIN THE ESTABLISHED LIMITS AND COMPARABLE TO THE HISTORICAL REAGENT LOT PERFORMANCE. A REVIEW OF INSTRUMENT LOGS (ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS DATA) WAS PERFORMED. THE ANALYSIS SHOWED THAT THE COMPLAINT KIT REPEATEDLY TRIGGERED MESSAGE CODE 1044 AND SHOWED MUCH LOWER CORRECTED SIGNAL COUNTS FOR CONTROL LEVELS 1 AND 2 COMPARED TO OTHER KITS, INDICATING THAT THE PERFORMANCE OF THE COMPLAINT KIT WAS COMPROMISED. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I STAT HIGH SENSITIVITY TROPONIN-I ASSAY FOR LOT 75636UD00 WAS IDENTIFIED. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). 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 (ALINITY I STAT HIGH SENSITIVE TROPONIN-I) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4Z21 (ALINITY I STAT HIGH SENSITIVITY TROPONIN-I) WITH 510K/PMA/BLA NUMBER K202525. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR ONE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED: (CUSTOMER REFERENCE RANGE: FEMALE 18-(B)(6) YEARS: <14 NG/L MALE 18-(B)(6) YEARS: <44 NG/L). SID: (B)(60, 77-YEAR-OLD FEMALE PATIENT WAS ADMITTED FOR SUSPECTED HEART THROMBOSIS DUE TO PREVIOUS BLOOD TESTS WHERE TROPONIN WAS ELEVATED. THE PATIENT HAD BLOOD TESTS THAT INCLUDED THE TROPONIN OF <1.30 NG/L, AND SAMPLE WAS RETESTED THE NEXT DAY (B)(6) 2025 WITH RESULT OF 1031 NG/L. THE PATIENT WAS GIVEN A CLINICAL DIAGNOSIS IS CORONARY ARTERY STENOSIS AND ISCHEMIA. THE CUSTOMER REPORTED THE PATIENT'S FURTHER EXAMINATIONS AND TREATMENT FOR A HEART THROMBOSIS WERE DELAYED FOR A DAY. THE MEDICAL TREATMENT CONSISTED OF A BOLUS OF HEART MAGNYL 300MG AND THE PATIENT SCHEDULED FOR DILATION OF THE STENOSIS WITH CARDIAC ANGIOGRAPHY (CAG) AND PERCUTANEOUS CORONARY INTERVENTION (PCI). THE CUSTOMER REPORTED THE PATIENT IS DOING OK NOW. DURING REVIEW OF THE LOGS THE CUSTOMER IDENTIFIED THE INSTRUMENT WAS GENERATING ERROR CODE EC 1044 (UNABLE TO CALCULATE RESULT. FINAL RLU READ IS OUTSIDE THE SPECIFICATION OF LOWEST CALIBRATOR VALUE) ON (B)(6) 2025. THE CUSTOMER RERAN SAMPLES FROM (B)(6) 2025 THE NEXT DAY ON (B)(6) 2025 AND IDENTIFIED DISCREPANT TROPONIN RESULTS. UPON FURTHER REVIEW, THE CUSTOMER NOTED THAT QUALITY CONTROLS (QC) WERE RUN AND WITHIN RANGE FOR LOT 75636UD00. HOWEVER, A NEW CARTRIDGE WAS LOADED, AND THE LABORATORY DOES NOT RUN QC WITH EACH REAGENT CARTRIDGE. NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULTS FOR MULTIPLE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED: (CUSTOMER REFERENCE RANGE: FEMALE 18-(B)(6) YEARS: <14 NG/L MALE 18-(B)(6) YEARS: <44 NG/L). SID: (B)(6) 77-YEAR-OLD FEMALE PATIENT WAS ADMITTED FOR SUSPECTED HEART THROMBOSIS DUE TO PREVIOUS BLOOD TESTS WHERE TROPONIN WAS ELEVATED. THE PATIENT HAD BLOOD TESTS THAT INCLUDED THE TROPONIN OF <1.30 NG/L, AND SAMPLE WAS RETESTED THE NEXT DAY (B)(6) 2025 WITH RESULT OF 1031 NG/L. THE PATIENT WAS GIVEN A CLINICAL DIAGNOSIS IS CORONARY ARTERY STENOSIS AND ISCHEMIA. THE CUSTOMER REPORTED THE PATIENT'S FURTHER EXAMINATIONS AND TREATMENT FOR A HEART THROMBOSIS WERE DELAYED FOR A DAY. THE MEDICAL TREATMENT CONSISTED OF A BOLUS OF HEART MAGNYL 300MG AND THE PATIENT SCHEDULED FOR DILATION OF THE STENOSIS WITH CARDIAC ANGIOGRAPHY (CAG) AND PERCUTANEOUS CORONARY INTERVENTION (PCI). THE CUSTOMER REPORTED THE PATIENT IS DOING OK NOW. DURING REVIEW OF THE LOGS THE CUSTOMER IDENTIFIED THE INSTRUMENT WAS GENERATING ERROR CODE EC 1044 (UNABLE TO CALCULATE RESULT. FINAL RLU READ IS OUTSIDE THE SPECIFICATION OF LOWEST CALIBRATOR VALUE) ON (B)(6) 2025. THE CUSTOMER RERAN SAMPLES FROM (B)(6) 2025 THE NEXT DAY ON (B)(6) 2025 AND IDENTIFIED DISCREPANT TROPONIN RESULTS. UPON FURTHER REVIEW, THE CUSTOMER NOTED THAT QUALITY CONTROLS (QC) WERE RUN AND WITHIN RANGE FOR LOT 75636UD00. HOWEVER, A NEW CARTRIDGE WAS LOADED, AND THE LABORATORY DOES NOT RUN QC WITH EACH REAGENT CARTRIDGE. NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386510 ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 75636UD00

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)