BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PTPLUS CARTRIDGE

    MDR report key: 20557262 · Received October 29, 2024

    Report

    Report Number
    2245578-2024-00196
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 16, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GJS
    PMA / PMN Number
    K220282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 25-NOV-2024. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT PASSED RELEASE SPECIFICATIONS. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # 964571 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 22-OCT-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT PLUS CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT ON A 84 YEAR OLD FEMALE PATIENT IN FOR AN MITRAL VALVE REPLACEMENT. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED INR SAMPLE I-STAT 16-OCT-24 11:14 IMMEDIATELY 4.4 FINGERSTICK I-STAT 16-OCT-24 11:14 11:24 2.7 FINGERSTICK AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY. INTENDED USE: THE I-STAT PTPLUS CARTRIDGE IS INTENDED FOR USE IN THE IN VITRO QUANTITATIVE MEASUREMENT OF THE CLOT TIME OF THE EXTRINSIC COAGULATION PATHWAY WHEN ACTIVATED BY THROMBOPLASTIN IN NON-ANTICOAGULATED WHOLE BLOOD (VENOUS OR CAPILLARY), USING THE I-STAT 1 SYSTEM. MEASUREMENTS OF PROTHROMBIN TIME ARE USED TO AID IN THE MONITORING OF PATIENTS RECEIVING ANTICOAGULANT THERAPY WITH COUMARIN DERIVATIVES. THE I-STAT PTPLUS PT TEST RESULT IS REPORTED IN SECONDS AND AS AN INR. THE TEST IS INTENDED FOR POINT OF CARE USE AND IS FOR PRESCRIPTION USE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978968 I-STAT PTPLUS CARTRIDGE PTPLUS CARTRIDGE GJS ABBOTT POINT OF CARE NA C24209A

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female