BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC4+ CARTRIDGE

    MDR report key: 9171500 · Received October 9, 2019

    Report

    Report Number
    2245578-2019-00230
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    August 2, 2019
    Report Date
    December 4, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JGS
    UDI-DI
    10054749000095
    PMA / PMN Number
    K912387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 12/04/2019. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS (FG) RELEASE CRITERIA. DUE TO THE EXPIRATION DATE OF EC4+ LOT K18306, RETAIN TESTING COULD NOT BE PERFORMED. RETAINED TESTING FOR EC4+ LOTS K18231 AND K19010 MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AD (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN DETERMINED FOR EC4+ LOTS K18231, K18306 AND K19010.

    Description of Event or Problem · 0

    NA.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC4+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULTS ON A (B)(6) YEAR OLD MALE PATIENT HAVING OUT-PATIENT SURGICAL PROCEDURE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. (B)(6). THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967228 I-STAT EC4+ CARTRIDGE EC4+ CARTRIDGE JGS ABBOTT POINT OF CARE NA K19010 10054749000095

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR