BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 8842653 · Received July 30, 2019

    Report

    Report Number
    2245578-2019-00192
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 24, 2019
    Report Date
    September 11, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT #: (B)(4). THE INVESTIGATION WAS COMPLETED ON 09/10/2019. IN RESPONSE TO RECEIVING A POST-MARKET SURVEILLANCE SURVEY FOR BLUE CTNI CARTRIDGES, THE CUSTOMER REPORTED OBSERVING POSITIVE I-STAT CTNI RESULTS THAT WERE CONSIDERED DISCREPANT FROM THE LABORATORY INSTRUMENT RESULTS. THE CUSTOMER DID NOT DISCLOSE ANY NUMERICAL RESULTS, CARTRIDGE LOTS OR A SPECIFIC TIME FRAME DURING WHICH THE DISCREPANT RESULTS WERE OBSERVED. NO RELEVANT ISSUES WERE IDENTIFIED THROUGH A REVIEW OF QUALITY SYSTEM INFORMATION. NO DEFICIENCY HAS BEEN IDENTIFIED.

    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. NOTE: THIS INCIDENT WAS RECEIVED AS PART OF THE ABBOTT POINT OF CARE ACTIVE MONITORING PROGRAM Q3 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 ON A PATIENT. THE CUSTOMER STATED THAT THEY ARE UNABLE TO PROVIDE SPECIFIC DETAILS, OTHER THAN (PLASMA) NEGATIVE ON ORTHO VITROS, AND POSITIVE ON I-STAT. THE CUSTOMER DID NOT PROVIDE ACTUAL I-STAT OR LAB RESULTS. THIS INCIDENT WAS RECEIVED AS PART OF THE ABBOTT POINT OF CARE ACTIVE MONITORING PROGRAM Q3 2019. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. CARTRIDGE LOT# INFORMATION IS ALSO UNKNOWN. THE FACILITY REPORTED THAT MOST OF COMPLAINTS VOICED REGARDING CTNI ARE REPORTED BY THE EMERGENCY ROOM AND INVESTIGATED BY THE LABORATORY. THIS IS NOT OFTEN AND OFTEN RESOLVED INTERNALLY. CUSTOMER IS NOT AWARE OF ANY ADVERSE PATIENT REACTION. 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. 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
    637484 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA 10054749001986

    Patients

    Seq Age Sex Outcome Treatment
    1