BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 3952580 · Received July 23, 2014

    Report

    Report Number
    2245578-2014-00033
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 07/29/2014. RETURN PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION. HOWEVER, RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF >9.0 ON A (B)(6) YEAR OLD FEMALE PATIENT SAMPLE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. DATE: TIME: POTASSIUM: SAMPLE: (B)(6) 2014, 09:16, >9.0, A. (B)(6) 2014, 09:33, >9.0, B. THERE WERE NO INJURIES REPORTED WITH THIS EVENT. THE CUSTOMER STATES THAT THE SAMPLE WAS DRAWN FROM AN IV LINE. BASED ON THE INFORMATION AVAILABLE HEMOLYSIS COULD HAVE POTENTIALLY BEEN A FACTOR IN THE RESULT OF >9.0. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431109 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA J14113

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR