BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 8736066 · Received June 26, 2019

    Report

    Report Number
    2245578-2019-00160
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 17, 2019
    Report Date
    August 2, 2019
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    UDI-DI
    10054749001986
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 08/01/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED AND RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AD (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR CTNI CARTRIDGE LOT K19083A.

    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 (B)(6) 2019, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED SUSPECTED DISCREPANT TROPONIN RESULTS OF 0.13 ON A (B)(6) YEAR OLD MALE PATIENT WITH CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. (B)(6). AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. THERE IS NO FINAL DIAGNOSIS, NOR EKG INFORMATION PROVIDED. THE CUSTOMER STATED THERE WAS LIMITED INFORMATION TO PATIENT RECORDS DUE TO HIPAA LAWS. THERE WAS NO EVIDENCE THE PATIENT SUFFERED AN MYOCARDIAL INFARCTION. THE INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL: ART: 714258-00Q, 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527922 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA K19083A 10054749001986

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR