BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I PROCESSING MODULE

    MDR report key: 21659939 · Received March 20, 2025

    Report

    Report Number
    3016438761-2025-00184
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 2, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JJE
    UDI-DI
    00380740137366
    PMA / PMN Number
    K170317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE INSTRUMENT AND PERFORMED TROUBLE SHOOTING. THE SAMPLE, REAGENT 1 AND REAGENT 2 ALINITY PIPETTOR PROBES WERE ALL REPLACED AND CALIBRATED SINCE THE PROBES HAD NOT BEEN REPLACED OR CALIBRATED FOR MORE THAN A YEAR, WHICH RESOLVED THE ISSUE. NO ADDITIONAL DISCREPANT RESULT ISSUES HAVE BEEN REPORTED SINCE THE SERVICE ACTIVITY WAS COMPLETED. AN INSTRUMENT SERVICE HISTORY REVIEW FOR (B)(6) REVEALED NO ADDITIONAL SERVICE TICKET ASSOCIATED WITH DISCREPANT OR ERRATIC PATIENT RESULTS. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ALINITY I PROCESSING MODULE DID NOT IDENTIFY ANY SIMILAR ISSUES AS DESCRIBED IN THIS COMPLAINT. ADDITIONALLY, A REVIEW OF COMPLAINT AND TRENDING DATA ASSOCIATED WITH THE ALINITY PIPETTOR PROBES DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO NON-CONFORMANCES OR POTENTIAL NON-CONFORMANCES WERE IDENTIFIED. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I PROCESSING MODULE, SERIAL NUMBER (B)(6), OR THE ALINITY PIPETTOR PROBES 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.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I STAT HIGH SENSITIVE TROPONIN-I RESULT GENERATED FOR A 61-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0-14 NG/L): SAMPLE ID (B)(6), (B)(6) 2025 INITIAL RESULT = 96 NG/L, (B)(6) 2025 REPEAT RESULT = 5.4 NG/L, SAMPLE SENT TO ANOTHER HOSPITAL AND RESULT = 5 NG/L. PATIENT WAS SENT TO ANOTHER HOSPITAL WHERE A NEW SAMPLE WAS OBTAINED AND RUN TWICE. RESULTS = <10 NG/L, <10 NG/L . 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 GENERATED FOR A 61-YEAR-OLD FEMALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 0-14 NG/L): SAMPLE ID: (B)(6), ON (B)(6) 2025 INITIAL RESULT = 96 NG/L, ON (B)(6) 2025 REPEAT RESULT = 5.4 NG/L, SAMPLE SENT TO ANOTHER HOSPITAL AND RESULT = 5 NG/L. PATIENT WAS SENT TO ANOTHER HOSPITAL WHERE A NEW SAMPLE WAS OBTAINED AND RUN TWICE. RESULTS = <10 NG/L, <10 NG/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334673 ALINITY I PROCESSING MODULE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ABBOTT LABORATORIES 00380740137366

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female ALIN I HS TNI 200T US, 04Z21-25, 70630UD00| ALIN I HS TNI 200T US, 04Z21-25, 70630UD00| ALINITY PIPETTOR PROBES, 03R96-01, UNKNOWN| ALINITY PIPETTOR PROBES, 03R96-01, UNKNOWN