BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 11627421 · Received April 7, 2021

    Report

    Report Number
    2245578-2021-00029
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    March 24, 2021
    Report Date
    June 22, 2021
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    GJS
    UDI-DI
    10054749000170
    PMA / PMN Number
    K020355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(6) 2021. THE CUSTOMER REPORTED AN UNEXPECTED RESULT WHEN TESTING WITH PT/INR CARTRIDGE LOT T20356. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE CARTRIDGE LOT PASSED RELEASE SPECIFICATIONS. WHILE RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AF (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE), PT/INR CARTRIDGE LOT T20356 IS ASSOCIATED WITH AN UNRELATED PREVIOUSLY IDENTIFIED DEFICIENCY FOR INCREASED RATE OF QUALITY CHECK CODE 19/STAR OUTS WHEN TESTED WITH WHOLE BLOOD, AS DOCUMENTED IN QUALITY RECORD 770729.

    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-MAR-2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULTS OF 2.9 A (B)(6) YEAR OLD FEMALE PATIENT WITH HYPER KALEMIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2021, COLLECTED: 15:14, TESTED: 15:14, RESULT: 2.9, SAMPLE: A. METHOD: STAGO, DATE: (B)(6) 2021, COLLECTED: 15:27, TESTED:15:29, RESULT: 7.15, SAMPLE: B. 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
    526708 I-STAT PT/INR CARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE NA T20356 10054749000170

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR