BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 4102790 · Received September 19, 2014

    Report

    Report Number
    2245578-2014-00064
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 10/30/2014. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. RETAIN CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(4) 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 60 YEAR OLD MALE PATIENT WHO PRESENTED WITH CARDIOGENIC SHOCK / TACHYCARDIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RESULTS FROM (B)(6) 2014: 16:15 HOSPITAL 1 MAIN LAB (INSTRUMENT UNKNOWN): K= 4.7; 18:24 AIR MEDICAL TRANSPORT (NO RETEST) I-STAT: K= >9.0 (PATIENT RECEIVED IV CACL2); 19:20 HOSPITAL 2 MAIN LAB (INSTRUMENT UNKNOWN): K= 4.7 (SAMPLE COLLECTED FROM ARTERIAL LINE). THE PATIENT WAS ADMINISTERED CACL2 BASED ON THE I-STAT RESULTS, HOWEVER THERE WERE NO INJURIES REPORTED WITH THIS EVENT. THE CUSTOMER REPORTED THE SAMPLE WAS WHOLE BLOOD AND VISUAL INSPECTION DURING TRANSPORT DETERMINED IT WAS NOT HEMOLYZED. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583944 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA J14154

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other