BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT®/DE SOFTWARE

    MDR report key: 6833877 · Received August 31, 2017

    Report

    Report Number
    2245578-2017-00281
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 31, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JQP
    PMA / PMN Number
    NA
    Removal / Correction Number
    APOC2017-005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WERE PROVIDED WITH THE ACTION THAT WAS CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION APOC PRODUCT ACTION NUMBER: (B)(4). PRODUCT NAME: LIST NUMBER: PART NUMBER: PRIMARY VERSION : VERSION: QUALIFIER, UDI. I-STAT®/DE SOFTWARE , 08K46-01, 115200, 047659-01, 2.8 , N/A, 00054749001255.

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN COMPLETED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. I-STAT/DE IS A SOFTWARE PRODUCT WHICH FACILITATES THE ADMINISTRATION OF THE I-STAT 1 SYSTEM THROUGH DATA MANAGER SOFTWARE SOLD BY THIRD PARTY VENDORS, OR BY ABBOTT POINT OF CARE. ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THROUGH INVESTIGATION OF CUSTOMER COMPLAINTS THAT THE REFERENCE RANGES, ACTION RANGES AND CUSTOMER REPORTABLE RANGES FOR ALL ANALYTES ARE RESET TO DEFAULT VALUES AFTER UPGRADING TO VERSION 2.8. ADDITIONALLY, LOCATION, OPERATOR, AND PATIENT LISTS STORED IN THE I-STAT 1 HANDHELD WILL NOT UPDATE AFTER UPGRADING TO I-STAT/DE VERSION 2.8 FROM AN EARLIER VERSION. NO ERRONEOUS RESULTS ARE GENERATED ON THE I-STAT HANDHELD AS A RESULT OF THIS ISSUE. IT IS IMPORTANT TO NOTE THAT ANY CUSTOMIZED RANGES (REFERENCE, ACTION AND REPORTABLE) WILL BE RESET TO FACTORY DEFAULT. PATIENT RESULTS ARE ACCESSIBLE IN THE I-STAT HANDHELD AND ALL OF THE ASSOCIATED INFORMATION THERE IS CORRECT. ADDITIONALLY, ALL MEASURED OR CALCULATED PARAMETERS PERFORMED BY THE I-STAT HANDHELD REMAIN ACCURATE AND ARE NOT IMPACTED. THERE HAVE NOT BEEN ANY INJURIES ASSOCIATED WITH THIS ISSUE. TWO MDRS HAVE BEEN FILED WITH FDA. THERE HAS NOT BEEN ANY ADVERSE EVENT OR ADVERSE REACTION REPORTS FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616087 I-STAT®/DE SOFTWARE I-STAT DE JQP ABBOTT POINT OF CARE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1