BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG4+ CARTRIDGE

    MDR report key: 18521352 · Received January 16, 2024

    Report

    Report Number
    2245578-2024-00010
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    December 31, 2023
    Report Date
    February 9, 2024
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    KHP
    UDI-DI
    10054749000132
    PMA / PMN Number
    K982071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 31-JAN-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. AL (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CG4+ CARTRIDGE LOT M23227.

    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

    ON 02-JAN-2024, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT PO2 RESULT ON A 185 MMHG ON A 63 YEAR OLD MALE PATIENT WITH END-STAGE CHRONIC RENAL FAILURE ON REGULAR DIALYSIS, TYPE 2 DIABETES, HYPERTENSION, PNEUMONIA , LIPID DISORDERS, AND GASTROESOPHAGEAL REFLUX. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED PO2 SO2 SAMPLE I-STAT (B)(6) 223 0949 25 MMHG 40% A I-STAT (B)(6) 223 NI 185 MMHG 99.6 B 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854439 I-STAT CG4+ CARTRIDGE CG4+ CARTRIDGE KHP ABBOTT POINT OF CARE NA M23227 10054749000132

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male