BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGE

    MDR report key: 12625496 · Received October 13, 2021

    Report

    Report Number
    2245578-2021-00081
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 7, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4)2021. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE CARTRIDGE LOTS PASSED RELEASE SPECIFICATIONS. RETAINED CARTRIDGE TESTING OF PT/INR CARTRIDGE LOT T21096B DOES NOT MEET THE ACCEPTANCE CRITERION FOR POINTS OUTSIDE TOTAL ALLOWABLE ERROR AS OUTLINED IN THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AG (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). THIS DEFICIENCY WAS PREVIOUSLY IDENTIFIED AND QUALITY RECORD (QR) 780205 WAS INITIATED TO ADDRESS ROOT CAUSE. RETAINED CARTRIDGE TESTING OF PT/INR CARTRIDGE LOT T21135B MEETS THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AG (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). PT/INR CARTRIDGE LOTS T21096B AND T21135B ARE ASSOCIATED WITH A PREVIOUSLY IDENTIFIED DEFICIENCY FOR QUALITY CHECK CODE (QCC) 19 AND/OR STAR OUTS WHEN TESTED WITH WHOLE BLOODS WITH ANALYTE VALUES NEAR THE LOWER END OF THE REPORTABLE RANGE. THE ISSUE IS NOT RELATED TO UNEXPECTED RESULTS. QR 770729 HAS BEEN INITIATED TO ADDRESS ROOT CAUSE.

    Description of Event or Problem · 0

    NA.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT #: (B)(4). ADDITIONAL CARTRIDGE LOT INFORMATION. PT/INR LOT#: T21096B MFG DATE: 06-APR-2021, EXP DATE: 03-OCT-2021. APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2021, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT PT/INR CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT PT/INR RESULT OF 2.0 ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. CUSTOMER WAS USING PT/INR LOTS T21135B & T21096B AND CANNOT ASSOCIATE CARTRIDGE LOT WITH RESULT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD:I-STAT , INR: 2.0. METHOD: LAB , INR: 3.6. COLLECTION AND TEST TIMES WERE NOT PROVIDED. 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
    1525183 I-STAT PT/INR CARTRIDGE PT/INR CARTRIDGE GJS ABBOTT POINT OF CARE NA T21135B 10054749000170

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown