BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT1 ANALYZER

    MDR report key: 6938652 · Received October 10, 2017

    Report

    Report Number
    2245578-2017-00543
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    September 23, 2015
    Report Date
    October 10, 2017
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CGA
    UDI-DI
    00054749000340
    PMA / PMN Number
    K001387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO INVESTIGATION PERFORMED. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. INVESTIGATION: N/A. ASSESSMENT: NO REPEATS ON THE I-STAT OR LABORATORY INSTRUMENT. THE REPORTER INDICATED THAT THE SAME SAMPLE WAS TESTED ON BOTH THE I-STAT AND THE LAB INSTRUMENT. THE I-STAT RESULTS WOULD BE CONSISTENT WITH A SAMPLE DRAWN INTO AN EDTA TUBE. ONLY SAMPLES COLLECTED IN UN-HEPARINIZED OR LITHIUM OR SODIUM HEPARINIZED BLOOD COLLECTION DEVICES MAY BE USED FOR TESTING USING ANY OF THE I-STAT CHEMISTRY CARTRIDGES. EDTA MAY NOT BE USED WITH ANY CARTRIDGE TYPE OTHER THAN THE GLUCOSE OR BNP CARTRIDGES. EDTA WILL CAUSE A CLINICALLY SIGNIFICANT ERROR IN SODIUM, POTASSIUM, CHLORIDE AND HEMATOCRIT RESULTS AND MAY AFFECT OTHER CHEMISTRY TESTS (B)(6) - SAMPLE COLLECTION). USE OF AN EDTA TUBE WOULD DECREASE THE IONIZED CALCIUM AND INCREASE K+. NO INFORMATION REGARDING THE PATIENT, SAMPLE TYPE OR SAMPLE HANDLING WERE AVAILABLE UPON REPEATED FOLLOW UP.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT1 ANALYZER (B)(4) THAT HAD LOWER RESULTS ON K AND NA ON A PATIENT. THERE WAS NO PATIENT INFORMATION AT THE TIME OF THIS REPORT. THERE WAS NO REPEAT ON I-STAT. NO REPLY FROM THE CUSTOMER. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. TEST: NA, I-STAT: 121, CHEMISTRY MACHINE: 140; TEST: K, I-STAT: >9, CHEMISTRY MACHINE: 5.0. AT THE TIME OF THE EVENT THERE WAS NO INDICATION OF A PRODUCT MALFUNCTION BASED ON THE INFORMATION PROVIDED AND ASSESSED BY APOC, HOWEVER THIS MDR IS A RETROSPECTIVE FILING IN RESPONSE TO AN OBSERVATION FROM AN FDA INSPECTION CONDUCTED MAY 8TH TO 12TH, 2017 AT ABBOTT POINT OF CARE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716912 I-STAT1 ANALYZER I-STAT1 ANALYZER CGA ABBOTT POINT OF CARE NA NA 00054749000340

    Patients

    Seq Age Sex Outcome Treatment
    1