BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT G3+ CARTRIDGE

    MDR report key: 1821319 · Received August 26, 2010

    Report

    Report Number
    2245578-2010-00112
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 24, 2006
    Report Date
    August 25, 2010
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WILL BE PROVIDED TO THE U.S FOOD AND DRUG ADMINISTRATION DISTRICT OFFICE. DURING THE (B)(6) FDA INSPECTION CONDUCTED BETWEEN (B)(6) 2010, ABBOTT POINT OF CARE (APOC) AND THE INVESTIGATOR DISCUSSED A 2006 FIELD ACTION THAT APOC HAD DETERMINED AT THAT TIME TO BE RECORDABLE PER 21 CFR 820 AND ITS THEN-APPLICABLE RISK EVALUATION PROCEDURE. PER THE RECOMMENDATION OF THE INVESTIGATOR, APOC IS NOW REPORTING THIS ACTION PER 21 CFR 806. APOC PRODUCT ACTION NUMBER (B)(4). ADDITIONAL INFO: CATALOG#: 06F03-02.

    Description of Event or Problem · 1

    ABBOTT POINT OF CARE IS FILING THE CITED FIELD ACTION ON (B)(6) 2010 AS PER THE RECOMMENDATION OF THE FDA INVESTIGATOR. THIS FIELD ACTION WAS PREVIOUSLY COMPLETED, EFFECTIVENESS CHECKS PERFORMED AND NO FURTHER ACTION WILL BE TAKEN WITH END USE CUSTOMERS AS THE PRODUCTS ASSOCIATED WITH THESE TWO ACTIONS ARE NOW EXPIRED. ABBOTT POINT OF CARE PRODUCT ASSOCIATED WITH THE ACTION EXPIRED IN 2006. (B)(4), EXPIRE 11/14/2006, (B)(4), EXPIRE 11/14/2006, (B)(4), EXPIRE 11/14/2006, AND (B)(4), EXPIRE 11/14/2006. THIS ACTION WILL BE CONDUCTED IN COOPERATION WITH THE U.S FOOD AND DRUG ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT G3+ CARTRIDGE G3+ CARTRIDGE JJE ABBOTT POINT OF CARE J06072

    Patients

    Seq Age Sex Outcome Treatment
    1