BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 19696426 · Received July 8, 2024

    Report

    Report Number
    2245578-2024-00136
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 30, 2024
    Report Date
    August 27, 2024
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 22-AUG-2024. 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. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOT S24121.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    NA.

    Description of Event or Problem · 0

    ON 01-JUL-2024, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE RESULT OF 3.05 NG/ML ON A 77 YEAR OLD FEMALE PATIENT WITH SYNCOPE. PATIENT WAS TRANSFERRED TO CHH MAIN HOSPITAL ED WHERE THE HIGH SENSITIVITY TROPONIN WAS RUN X2 ABOUT AN HOUR APART. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED CTNI(NG/ML) I-STAT 30-JUNE-2024 09:27 IMMEDIATELY 3.05 I-STAT 30-JUNE-2024 10:07 IMMEDIATELY 0.00 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
    150988 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA S24121

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male