BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNL) CARTRIDGE

    MDR report key: 22904007 · Received August 27, 2025

    Report

    Report Number
    2245578-2025-00101
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 17, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 26-SEP-2025. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AO (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR HS-TNI CARTRIDGE LOT A25126A.

    Description of Event or Problem · 0

    ON (B)(6) 2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 36-YEAR-OLD FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION, NOR DETAILS SURROUNDING THE EVENT AT THE TIME OF THIS REPORT. METHOD: I-STAT HS-TNL, DATE: (B)(6) 2025, COLLECTED: 1742, RESULT: 1742, SAMPLE: 545.1 NG/L WB LITHIUM HEPARIN, POSITIVE/NEGATIVE: POSITIVE. METHOD: BECKMAN HS-TNL, DATE: (B)(6) 2025, COLLECTED: 17:21, RESULT: 18:12, SAMPLE: <2.3 NG/L, POSITIVE/NEGATIVE: NEGATIVE. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THERE IS NO EVIDENCE THE PATIENT SUFFERED AN MI. PER I-STAT SYSTEM MANUAL: ART: 715595-00V, REPORTABLE RANGE: 0.00 - 50.00, REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS), REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESSULTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251272 I-STAT TROPONIN (HS-TNL) CARTRIDGE HS-TNL CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA A25126A

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female