BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CREA CARTRIDGE

    MDR report key: 12084227 · Received June 29, 2021

    Report

    Report Number
    2245578-2021-00057
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 22, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CGL
    UDI-DI
    10054749000125
    PMA / PMN Number
    K973292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 26-JUL-2021. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT PASSED FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE APPLICABLE ACCEPTANCE CRITERIA FOUND IN Q04.01.003 REV. AG, APPENDIX 1- PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE. NO DEFICIENCY HAS BEEN IDENTIFIED FOR CREA CARTRIDGE LOT A21134.

    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 25-JUN-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT CREA CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT CREATININE RESULT OF 2.9 ON AN 84 YEAR OLD FEMALE PATIENT PRESENTED FOR A STUDY SCAN AND ANGIOGRAM. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD:I-STAT ; RESULT : 2.9; DATE : (B)(6) 2021; TIME: 15:00. LAB , 0.9 , (B)(6) 2021 , 23:32. 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
    983837 I-STAT CREA CARTRIDGE CREA+ CARTRIDGE CGL ABBOTT POINT OF CARE NA A21134 10054749000125

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR