BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I STAT HIGH SENSITIVITY TROPONIN-I

    MDR report key: 17814596 · Received September 25, 2023

    Report

    Report Number
    3005094123-2023-00258
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    September 6, 2023
    Report Date
    November 8, 2023
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740194079
    PMA / PMN Number
    K202525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: ADDITIONAL INFORMATION IN SECTION D4 - EXPIRATION DATE UPDATED FROM BLANK TO 12/19/2023, AND SECTION H4 - DEVICE MFG DATE UPDATED FROM BLANK TO 7/10/2023. 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 IN HOUSE TESTING OF A RETAINED REAGENT KIT LOT 54072UD00. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE COMPLAINT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. TICKET TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT LOT/ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS WITH THE COMPLAINT LOT. IN-HOUSE TESTING WAS COMPLETED USING PANELS WHICH MIMIC PATIENT SAMPLES USING AN IN-HOUSE RETAINED KIT. ALL SPECIFICATIONS WERE MET INDICATING THAT LOT 54072UD00 IS PERFORMING ACCEPTABLY. 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 54072UD00 WAS IDENTIFIED.CORRECTED INFORMATION IN MULTIPLE SECTIONS OF G1: CONTACT OFFICE ADDRESS 1, CONTACT OFFICE CITY, CONTACT OFFICE POSTAL CODE, CONTACT OFFICE EMAIL, CONTACT OFFICE COUNTRY, CONTACT OFFICE FIRST NAME, CONTACT OFFICE LAST NAME, CONTACT OFFICE PHONE NUMBER, CONTACT OFFICE FAX NUMBER.

    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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 0 PG/ML, REPEAT = 19 PG/ML, REPEAT ON ANOTHER ANALYZER = 0 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVITY TROPONIN-I RESULT FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT = 0 PG/ML, REPEAT = 19 PG/ML, REPEAT ON ANOTHER ANALYZER = 0 PG/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724437 ALINITY I STAT HIGH SENSITIVITY TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 54072UD00 00380740194079

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).