BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 5831439 · Received July 28, 2016

    Report

    Report Number
    2245578-2016-00071
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    July 10, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    PMA / PMN Number
    K053110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (B)(6) 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 07/12/2016, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CHEM8+ CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT RESULTS ON A (B)(6) FEMALE PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. NEW INFORMATION WAS RECEIVED ON 07/20/2016 THAT INVOLVED REPEAT TESTING ON I-STAT THAT SUGGESTED A POTENTIAL PRODUCT MALFUNCTION. THE CUSTOMER ALSO STATES THAT RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THE INVESTIGATION IS UNDERWAY. DATE: (B)(6) 2016, TIME: 15:40, METHOD: I-STAT, LOT: H16038, NA: 118, CI >140; (B)(6) 2016, UNK, I-STAT, H16038, 141, 104, COMMENT: RECEIVED ON 7/20/2016. 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
    483513 I-STAT CHEM8+ CARTRIDGE CHEM8+ CARTRIDGE JGS ABBOTT POINT OF CARE NA H16038

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR