BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER, IMMUNO READY, WIRELESS

    MDR report key: 13789987 · Received March 16, 2022

    Report

    Report Number
    2245578-2022-00042
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    March 3, 2022
    Report Date
    July 26, 2022
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CGA
    UDI-DI
    00054749000340
    PMA / PMN Number
    K001387
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 22-JUL-2022. FAILURE ANALYSIS CONFIRMED THE CUSTOMER COMPLAINTS OF FAILURE TO ACTIVATE AS WELL AS UNEXPECTED POWER-DOWN. THE CAUSE WAS DETERMINED TO BE THE FAILURE OF MULTIPLE COMPONENTS IN THE VBATT AND VBB CIRCUIT, WHICH ALSO CONTRIBUTED TO THE SMOKE REPORTED BY THE (B)(4) 112017 WAS FOUND TO BE HAVE FAILED WHICH LIKELY CAUSED THE COMPONENT FAILURE IN ANALYZER S/N (B)(4) AS WELL AS THE SMOKE AND THE WARM TO TOUCH CONDITION WHEN DOCKED IN THE DRC AT THE CUSTOMER SITE. IT SHOULD BE NOTED THAT THE ANALYZER RECHARGEABLE BATTERY AS WELL AS THE DRC POWER SUPPLY AND POWER CABLE THAT WERE IN USE AT THE TIME OF THE INCIDENT WERE NOT RETURNED AND CANNOT BE RULED OUT AS CONTRIBUTING FACTORS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED OBSERVING SMOKE COMING FROM THE COMPARTMENT OF I-STAT ANALYZER SN (B)(4) DURING OPERATION. THE PRODUCT DID NOT BECOME HOT TO THE TOUCH. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. THERE WERE NO INJURIES REPORTED. THE ANALYZER WAS REPLACED AT NO CHARGE AND RETURNING FOR INVESTIGATION. 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. THE ANALYZER WAS OPERATING ON RECHARGEABLE BATTERIES AT THE TIME OF THE EVENT. AT THIS TIME THERE IS NO REASON TO BELIEVE PRODUCT WILL BECOME HOT TO THE TOUCH. THE PRODUCT WAS REPLACED AND RETURNING FOR INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO PATIENT OR USER RELATED INJURIES ASSOCIATED WITH THIS COMPLAINT.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780671 I-STAT1 ANALYZER, IMMUNO READY, WIRELESS I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA 00054749000340

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown