BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 13481626 · Received February 8, 2022

    Report

    Report Number
    2245578-2022-00022
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    January 22, 2022
    Report Date
    March 1, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    UDI-DI
    10054749000163
    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) 2021. RETAINED AND RETURNED (ASSOCIATED WITH ALL INCIDENTS UNDER INVESTIGATION) CARTRIDGE TEST RESULTS MET ALL ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE EXCEPT FOR RATE OF ICA RESULTS OUTSIDE TOTAL ALLOWABLE ERROR. A DEFICIENCY WAS PREVIOUSLY IDENTIFIED AND IS DOCUMENTED UNDER QUALITY RECORDS (B)(4).

    Description of Event or Problem · 0

    ON 26-JAN-2022, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CG8+ CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT IONIZED CALCIUM RESULT OF 2.39 ON A PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION. I-STAT, (B)(6) 2022, 2.39 MMOLL WB. LAB (B)(6) 2022, 1.37 MMOL/L WB. 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.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904049 I-STAT CG8+ CARTRIDGE CG8+ CARTRIDGE CHL ABBOTT POINT OF CARE NA W21198 10054749000163

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown