BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 16454290 · Received February 28, 2023

    Report

    Report Number
    2245578-2023-00024
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    October 23, 2022
    Report Date
    March 24, 2023
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    UDI-DI
    10054749000187
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 21-MAR-2023. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS MET FINISHED GOODS (FG) RELEASE CRITERIA. DUE TO EXPIRY PRIOR TO THE INVESTIGATION OPEN DATE (06-MAR-2023), RETAINED CARTRIDGE TESTING OF CTNI LOTS A22194 (EXPIRED 11-FEB-2023) AND A22208 (EXPIRED 25-FEB-2023) COULD NOT PERFORMED. RETAINED CARTRIDGE TESTING OF CTNI LOTS A22233 AND B22273 MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AK (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOTS A22194, A22208, A22233 OR B22273.

    Description of Event or Problem · 0

    ON (B)(6) 2023, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES AND ANALYZER THAT YIELDED A FALSE POSITIVE DISCREPANT RESULT OF 0.21 NG/ML ON AN 56 YEAR OLD FEMALE PATIENT WITH HISTORY OF ASTHMA, MS. ADMITTED WITH HYPOKALEMIA AND ALCOHOL INTOXICATION, & DIARRHEA. THE COMPLAINT WAS RECEIVED FROM AN ACTIVE MONITORING SURVEY FOR THE I-STAT CTNI CARTRIDGE. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. METHOD, DATE, TESTED, RESULT, SAMPLE: I-STAT, (B)6) 2022, 824, 0.21 NG/ML, WHOLE BLOOD; BECKMAN DXI, (B)(6) 2022, 835, <0.01 NG/ML, PLASMA. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTED THAT PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 715595-00V; REPORTABLE RANGE: 0.00 - 50.00; REFERENCE RANGE: 0.00 - 0.03 (REPRESENTS THE 0 TO 97.5% RANGE OF RESULTS); REFERENCE RANGE: 0.00 - 0.08 (REPRESENTS THE 0 TO 99% RANGE OF RESULTS).

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409613 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA A22208 10054749000187

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female