BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 13415722 · Received February 1, 2022

    Report

    Report Number
    2245578-2022-00017
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    January 12, 2022
    Report Date
    February 15, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000071
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2022. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT CARTRIDGE LOT K21158 PASSED FINISHED GOODS (FG) RELEASE CRITERIA. DUE TO EXPIRY, RETAINED CARTRIDGE TESTING COULD NOT BE PERFORMED. NO DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EC8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT POTASSIUM RESULT OF >9.0 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. EC8+; (B)(6) 2022; @12:24 AM; K+ 2.8 MMOL/L. EC8+; (B)(6) 2022; @5:19 AM; K+ >9 MMOL/L. EC8+; (B)(6) 2022; @10:39 AM; K+ 3.2 MMOL/L. THE CUSTOMER STATED THAT THEY SUSPECT BUT CANNOT CONFIRM THAT THE RESULT OF EC8+, (B)(6) 2022 @ 5:19 AM, K+ >9 MMOL/L WAS RUN ON A SAMPLE COLLECTED IN EDTA TUBE. CUSTOMER IS UNABLE TO PROVIDE ANY CARTRIDGES TO RETURN FOR INVESTIGATION FOR EC8+ LOT K21158 EXPIRED (B)(6) 2022. CUSTOMER IS AWARE THEY WERE USING EXPIRED CARTRIDGES AT THE TIME OF THE EVENT. 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 THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993646 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA K21158 10054749000071

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown