BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 5783927 · Received July 11, 2016

    Report

    Report Number
    2245578-2016-00047
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 23, 2016
    Report Date
    September 12, 2016
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 08/29/2016. RETAIN PRODUCT WAS TESTED AND IS FUNCTIONING ACCORDING TO SPECIFICATION. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    ON 07/06/2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT NA, & CI RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT AND THE CUSTOMER STATES THEY ARE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION FOR PATIENT. THE CUSTOMER ALSO STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. PATIENT: #3, LOT# H16124, TEST DATE: (B)(6) 2016, TIME: 1055, NA: 105, CL: >140; REPEAT, H16124, (B)(6) 2016, 1112, 138, 101. 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
    438288 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16124

    Patients

    Seq Age Sex Outcome Treatment
    1