BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG4+ CARTRIDGE

    MDR report key: 9673188 · Received February 5, 2020

    Report

    Report Number
    2245578-2020-00023
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 13, 2020
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    KHP
    UDI-DI
    10054749000132
    PMA / PMN Number
    K982071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 02/10/2020. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AD, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED.

    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) 2020, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT LACTATE RESULTS ON A (B)(6) YEAR OLD FEMALE PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, RESULT: 8.0 MMO/L, SAMPLE: A. I-STAT, 1.8 MMO/L, NI. COLLECT AND TEST TIMES NOT PROVIDED. 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
    133411 I-STAT CG4+ CARTRIDGE CG4+ CARTRIDGE KHP ABBOTT POINT OF CARE NA M19259 10054749000132

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR