BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 7297842 · Received February 26, 2018

    Report

    Report Number
    2245578-2018-00065
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 17, 2018
    Report Date
    March 23, 2018
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000163
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 03/12/2018. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AC, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. RETURNED CARTRIDGE TESTING FOR INCIDENT 748344 MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AC, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) YEAR OLD MALE PATIENT ADMITTED WITH ACUTE RESPIRATORY FAILURE, CARDIAC ARREST, PNEUMONIA AND SEPTIC SHOCK. UNDERGOING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE. TEST DATE: (B)(6) 2018. . COLLECT/TEST TIME: 10:23, 10:45, 11:09. PO2, 111, 159, 134. PCO2, 88.0, 34.6, 20.5. PH, 7.16, 7.50, 7.59. BE, 0, 4 , -1. HCO3, 31.3, 26.8, 19.4. HCT, 38.0, 33.0, 32.0. K+, 4.9, 5.1, 4.2. ICA+, 1.16 , 1.07, 0.96. GLU, 122, 122, 112. SO2 , 96.0, 100.0, 100.0. NA+, NOT REPORTED. HGB, NOT REPORTED. TCO2, NOT REPORTED. 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 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
    140655 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA W17250 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR