BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG4+ CARTRIDGE

    MDR report key: 15456262 · Received September 20, 2022

    Report

    Report Number
    2245578-2022-00138
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 11, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    KHP
    UDI-DI
    10054749000132
    PMA / PMN Number
    K982071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 04-OCT-2022. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE CARTRIDGE LOTS PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AK, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE, IN ALL CASES EXCEPT FOR LOT M22088 IN I-STAT LEVEL 2 (L2) CONTROL FLUID (TEST ID JB797A) WHERE THE SAMPLE SIZE WAS TOO LOW (<17) TO ASSESS POINTS OUTSIDE TOTAL ALLOWABLE ERROR (EA). NO DEFICIENCY HAS BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON 09-SEP-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG4+ CARTRIDGE THAT YIELDED A SUSPECTED DISCREPANT LACTATE RESULT ON A 69 YEAR OLD MALE PATIENT. THE PATIENT WAS ADMITTED AND DISCHARGED THE SAME DAY. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. METHOD: I-STAT, DATE: (B)(6) 2022, RESULT: 2.54 MMOL/L; EKF, (B)(6) 2022 1.2 MMOL/L; 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 THE 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
    2661017 I-STAT CG4+ CARTRIDGE CG4+ CARTRIDGE KHP ABBOTT POINT OF CARE NA M22087 10054749000132

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male