BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 1935701 · Received December 16, 2010

    Report

    Report Number
    2245578-2010-00164
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD
    Product Code
    JPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT 6+ CARTRIDGE YIELDED A SODIUM RESULT OF 135 MMOL/L ON THE FIRST TEST, 135 MMOL/L ON THE SECOND, AND 111 MMOL/L ON THE THIRD TEST. THERE WAS NO LAB RESULT. THERE WAS NO REPORT OF ANY INJURY OR IMPACT TO PT CARE ASSOCIATED WITH THE EVENT. NO PT OR MEDICATION INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT 6+ CARTRIDGE 6+ CARTRIDGE JPA ABBOTT POINT OF CARE CANADA LTD B10173

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other