BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT E3+ CARTRIDGE

    MDR report key: 3056060 · Received April 12, 2013

    Report

    Report Number
    2245578-2013-00064
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K912387
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2013. RETAIN AND RETURNED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT E3+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT HEMATOCRIT RESULT ON A PATIENT. THERE IS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. TIME: METHOD: HCT: SAMPLE: NI, I-STAT, 0.27, NI. NI, SIEMENS, 0.304, NI. AT THE TIME OF THIS REPORT, THERE WERE NO OTHER INJURIES ASSOCIATED WITH THIS EVENT. APOC BELIEVES THAT AN ADVERSE EVENT OCCURRED IN THE PATIENT RECEIVING AND UNNECESSARY TRANSFUSION BASED ON ONE I-STAT RESULT OF 27. AT THIS TIME THERE IS NO REASON TO BELIEVE THAT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    NA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158797 I-STAT E3+ CARTRIDGE E3+ CARTRIDGE JGS ABBOTT POINT OF CARE NA J12291A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention