BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 16325959 · Received February 8, 2023

    Report

    Report Number
    2245578-2023-00015
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 22, 2023
    Report Date
    February 28, 2023
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    UDI-DI
    10054749000187
    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#: 911638 (CARTRIDGE), APOC INCIDENT#: (B)(4). (I-STAT), SERIAL NUMBER: (B)(4). PRODUCT#: 06F16-10R, PMA/510K#: K103195, UDI: (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 22-FEB-2023. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AK (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOT A22226A.

    Description of Event or Problem · 0

    ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES AND ANALYZER THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.16 NG/ML ON A 34 YEAR OLD FEMALE PATIENT PRESENTED WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT (CARTRIDGE) IS NOT AVAILABLE FOR INVESTIGATION. CUSTOMER ALSO ALLEGING ANALYZER (SN: (B)(4) AND IT IS BEING REPLACED AND RETURNING FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT (UG/L) SAMPLE I-STAT ON (B)(6) 2023, 17:25, 17:30, 0.16, A, I-STAT ON (B)(6) 2023, 17:25, 17:42, 0.00, A, I-STAT ON (B)(6) 2023, 17:25, 17:51, 0.01, A. 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. 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).

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2312304 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA A22226A 10054749000187

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female