BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 21160284 · Received January 15, 2025

    Report

    Report Number
    2245578-2025-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 4, 2025
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 03-FEB-2025. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOT S24233.

    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 DESCREPANT FALSE POSITIVE RESULT OF 0.41 NG/ML ON AN (B)(6) MALE PATIENT. WITH RECENT PNEUMONIA, A HISTORY OF LOCALIZED PROSTATIC CANCER AND CORONARY ARTERY DISEASE, SHORTNESS OF BREATH, AND EPIGLOTTITIS. THE CUSTOMER STATED THAT THE PATIENT LATER PASSED AWAY IN ER DEPARTMENT (B)(6) @ 17:25. THE PATIENT'S FINAL DIAGNOSIS AND CAUSE OF DEATH WAS RML (RIGHT MIDDLE LOBE) PNEUMONIA. THE FAMILY WISHED FOR PALLIATIVE CARE ONLY WHEN PRESENTED TO ER. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE: RESULT: SAMPLE: I-STAT. (B)(6)2025. 0.41 NG/ML. A- WB. I-STAT. (B)(6)2025. 0.00 NG/ML. A- WB. I-STAT. (B)(6)2025. 0.01 NG/ML. B- WB. LAB/CCH. (B)(6)2025. 62 (NG/L HIGH SENS). NI. I-STAT TESTED IMMEDIATELY. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. 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. THE INVESTIGATION IS UNDERWAY. 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 RESULTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584188 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA S24233

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Female