BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER, IMMUNO READY

    MDR report key: 6819961 · Received August 25, 2017

    Report

    Report Number
    2245578-2017-00278
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    August 9, 2017
    Report Date
    November 17, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CGA
    UDI-DI
    00054749001408
    PMA / PMN Number
    K103195
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Additional Manufacturer Narrative · 1

    APOC INCIDENT # (B)(4). THE INVESTIGATION WAS COMPLETED ON 11/07/2017. THE FAILURE WAS DUE TO A DEFECTIVE TANTALUM CAPACITOR.

    Description of Event or Problem · 1

    ON (B)(6)2017, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) WAS FEELING "EXTREMELY HOT" AND NOT ACTIVATING . THE CUSTOMER ALSO STATED THAT THERE WAS NO INDICATION OF SMOKE, OR BURNING SMELL. THERE WAS NO IMPACT TO PATIENT CARE OR MANAGEMENT AS PATIENTS WERE TESTED ON OTHER I-STAT ANALYZERS. THE I-STAT WAS OPERATING WITH RECHARGEABLE BATTERIES. APOC HAS DETERMINED THAT A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY, MAY LEAD TO THE BATTERIES BECOMING UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT WHEN USING A GREEN NON-FUSED BATTERY CARRIER. HOWEVER, THE CUSTOMER STATES THAT RECHARGEABLE BATTERIES WERE BEING USED. THEREFORE THE ANALYZER IS UNLIKELY TO BECOME HOT TO TOUCH. THE PRODUCT WAS REPLACED AND RETURNED FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 1

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602019 I-STAT1 ANALYZER, IMMUNO READY I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA 00054749001408

    Patients

    Seq Age Sex Outcome Treatment
    1