BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 10635224 · Received October 6, 2020

    Report

    Report Number
    2245578-2020-00108
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    September 28, 2020
    Report Date
    December 2, 2020
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000040
    PMA / PMN Number
    K940918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2020. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAIN TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AF, APPENDIX 1 - PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN DETERMINED FOR EG7+ LOT N20193.

    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) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT EG7+ CARTRIDGES THAT YIELDED A SUSPECTED DESCREPANT HEMOGLOBIN RESULT OF 23.5 G/DL ON A PATIENT THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THE CUSTOMER HAS NOT RESPONDED TO MULTIPLE ATTEMPTS FOR INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED: RESULT (UNITS) : LAB: (B)(6) 2020; 13:10; 9.1 G/DL. I-STAT: (B)(6) 2020; 14:01; 10.5 G/DL. I-STAT: (B)(6) 2020; N14:46; 23.5 G/DL. I-STAT: (B)(6) 2020; 22.00; 7.8 G/DL. AT THIS TIME, THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON 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
    1103392 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE CHL ABBOTT POINT OF CARE NA N20193 10054749000040

    Patients

    Seq Age Sex Outcome Treatment
    1