BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER, IMMUNO READY

    MDR report key: 3803252 · Received May 9, 2014

    Report

    Report Number
    2245578-2014-00021
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    January 21, 2014
    Report Date
    February 4, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CGA
    PMA / PMN Number
    K001387
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE (APOC) DISTRIBUTOR REPAIR CENTER WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ANALYZER SN (B)(4) WOULD NOT ACTIVATE. THE ANALYZER WAS RETURNED FOR REPAIR AND DURING FAILURE ANALYSIS A BURNT CAPACITOR (C26) WAS DISCOVERED. APOC HAS DETERMINED THAT THE COMPONENT FAILURE IDENTIFIED 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 DOT NON-FUSED BATTERY CARRIER. PER PRODUCT ACTION (B)(4) , A RED DOT FUSED-BATTERY CARRIER WAS RELEASED TO MITIGATE THE ISSUE AND WAS SHIPPED TO THE CUSTOMER. ANALYZER SN (B)(4) WAS SHIPPED ON OR ABOUT (B)(4) 2005 AND HAS NEVER BEEN RETURNED TO APOC. APOC HAS NOT BEEN ABLE TO CONTACT THE CUSTOMER FOR INFORMATION ON WHICH BATTERY CARRIER CONFIGURATION WAS IN USE WITH ANALYZER SN (B)(4) AT THE TIME OF THIS EVENT. 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
    281488 I-STAT1 ANALYZER, IMMUNO READY I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1