BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 8736065 · Received June 26, 2019

    Report

    Report Number
    2245578-2019-00158
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    February 6, 2019
    Report Date
    July 17, 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
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 07/15/2019. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. RETAINED 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 K19043A.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT. NOTE: THIS INCIDENT WAS RECEIVED AS PART OF THE ABBOTT POINT OF CARE ACTIVE MONITORING PROGRAM Q2 2019.

    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 A SUSPECTED DISCREPANT TROPONIN RESULT OF 0.18 ON A PATIENT. THE CUSTOMER STATED THAT THE I-STAT RESULT DID NOT MATCH UP TO THE TESTING FROM OTHER LAB EQUIPMENT. THE CUSTOMER DID NOT PROVIDE THE LAB RESULTS. THIS INCIDENT WAS RECEIVED AS PART OF THE ABBOTT POINT OF CARE ACTIVE MONITORING PROGRAM Q2 2019. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, DATE: (B)(6) 2019, RESULT: 0.18; LAB, (B)(6) 2019, UNK. COLLECTION/TEST TIME, AND LAB RESULT NOT PROVIDED. POSITIVE CUT-OFF VALUE: NI. 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 AND NO EVIDENCE THE PATIENT SUFFERED A 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
    527593 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA K19043A 10054749001986

    Patients

    Seq Age Sex Outcome Treatment
    1