BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG4+ CARTRIDGE

    MDR report key: 20469593 · Received October 17, 2024

    Report

    Report Number
    2245578-2024-00193
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    October 11, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    KHP
    PMA / PMN Number
    K200492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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 01-NOV-2024. 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. AN, PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CG4+ CARTRIDGE LOT M24144.

    Description of Event or Problem · 0

    ON 14-OCT-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE TESTED PH PCO2 PO2 LAC SAMPLE I-STAT (B)(6) 2024 21:39 7.259 7.73 KPA 5.7 KPA 0.97 MMOL/L NI. LAB (B)(6) 2024 21:59 7.33 5.8 KPA 6.5 KPA 2.4 MMOL/L CAPILLARY. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463534 I-STAT CG4+ CARTRIDGE CG4+ CARTRIDGE KHP ABBOTT POINT OF CARE NA M24144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown