BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER, IMMUNO READY, WIRELESS

    MDR report key: 11231121 · Received January 26, 2021

    Report

    Report Number
    2245578-2021-00006
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 22, 2021
    Report Date
    April 20, 2021
    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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: 851234 THE INVESTIGATION WAS COMPLETED ON 19-APR-2021. THE CUSTOMER REPORTED THAT "SMOKE BURN" WAS SEEN INSIDE ANALYZER S/N 353367 AND THE BATTERY DOOR WAS OBSERVED BLACK IN COLOR. THE BUSINESS PARTNER ADDED THAT THE CABLES AND/OR BATTERIES IN USE WERE NOT PROVIDED BY APOC. THE CONCLUSION OF THE INVESTIGATION IS THAT THE COMPLAINT WAS CONFIRMED, AND THE LIKELY CAUSE WAS DETERMINED TO BE THE NON-APOC SUPPLIED BATTERIES AND/OR CABLES THAT WERE IN USE AS CONFIRMED BY THE BUSINESS PARTNER. A ROCKETWARE SEARCH SPANNING SIX MONTHS REVEALED NO SIMILAR INCIDENTS AND NO EVIDENCE OF A TREND. NO DEFICIENCY HAS BEEN IDENTIFIED.

    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 22-JAN-2021, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) SMOKE BURN WAS SEEN IN THE BATTERY COMPARTMENT AREA OF THE ANALYZER. THERE WAS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT. 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. CARRIER INFORMATION WAS NOT AVAILABLE. HOWEVER, THE ANALYZER SHIPPED ON 07-DEB-20212 WITH DISPOSABLE ALKALINE 9V DURACELL BATTERIES AND A RED CARRIER. THERE IS NO REASON TO SUSPECT THE PRODUCT WOULD 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126714 I-STAT1 ANALYZER, IMMUNO READY, WIRELESS I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA 00054749000340

    Patients

    Seq Age Sex Outcome Treatment
    1