BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG4+ CARTRIDGE

    MDR report key: 6805222 · Received August 18, 2017

    Report

    Report Number
    2245578-2017-00277
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    July 18, 2017
    Report Date
    November 10, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    KHP
    UDI-DI
    10054749002266
    PMA / PMN Number
    K982071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 11/03/2017. RETAIN PRODUCT WAS TESTED AND FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE/TIME COLLECTED , TEST TIME, PH, METHOD, SAMPLE, SAMPLE TYPE: (B)(6) 2017, 19:55PM, 20:03, 7.067 I-STAT, A , WB/VENOUS AND (B)(6) 2017, 20:35PM, 21:3,5 7.32 ABL800, B , WB/VENOUS. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586203 I-STAT CG4+ CARTRIDGE CG4+ CARTRIDGE KHP ABBOTT POINT OF CARE NA D17086C 10054749002266

    Patients

    Seq Age Sex Outcome Treatment
    1