BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CREATININE CARTRIDGE

    MDR report key: 20953800 · Received December 17, 2024

    Report

    Report Number
    2245578-2024-00217
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 10, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    CGL
    PMA / PMN Number
    K973292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 09-JAN-2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) 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 CREA CARTRIDGE LOT A24301.

    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 10-DEC-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULTS ON A 48 YEAR OLD MALE SEEN FOR A CT EXAM. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED RESULT-MG/DL SAMPLE I-STAT (B)(6) 2024 09:02 IMMEDIATELY 2.8 WB I-STAT (B)(6) 2024 09:11 IMMEDIATELY 2.5 WB I-STAT (B)(6) 2024 09:26 IMMEDIATELY 2.5 WB LAB (B)(6) 2024 09:38 NI 1.37 PLASMA THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720126 I-STAT CREATININE CARTRIDGE CREA CARTRIDGE CGL ABBOTT POINT OF CARE INC. NA A24301

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male