BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 18038119 · Received October 31, 2023

    Report

    Report Number
    2245578-2023-00148
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 6, 2023
    Report Date
    November 14, 2023
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    UDI-DI
    10054749000187
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 08-NOV-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. AL (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOT B23124.

    Description of Event or Problem · 0

    ON 17-OCT-2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD : RESULT : SAMPLE: I-STAT , NO RESULT PROVIDED , NI. I-STAT , <0.02 NG/ML , B. NO TEST/COLECT TIMES PROVIDED. 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 PATEINT 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
    2124832 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B23124 10054749000187

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female