BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 7917722 · Received September 28, 2018

    Report

    Report Number
    3010606081-2018-00014
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    August 30, 2018
    Report Date
    September 28, 2018
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE INVESTIGATION IT WAS FOUND THAT USER STORED STRIPS IN THE BATHROOM. PER USER GUIDE, USER SHOULD NOT STORE IN THAT LOCATION. THE CONTROL SOLUTION TEST RESULTS DEMONSTRATED THAT THE METER WORKED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    USER CONTACTED DARIO TO REPORT METER PROVIDED HIGH READINGS (RECEIVED "HIGH" MESSAGE). PER USER GUIDE IF THE RESULT IS HIGHER THAN 600 MG/DL THE FOLLOWING MESSAGE APPEARS - "HIGH! MEASURE WITH A NEW STRIP, IF RECURS CONTACT YOUR PHYSICIAN IMMEDIATELY". AS A RESULT, USER TOOK INSULIN. AFTERWARDS, HE DID NOT FEEL WELL AND WENT TO THE HOSPITAL. HE HAD HYPOGLYCEMIA. USER STORED TEST STRIPS IN THE BATHROOM CABINET. PER USER GUIDE, "DO NOT STORE OR USE METER OR TEST STRIPS IN AN AREA WHERE THE HUMIDITY IS OUTSIDE OF THE RANGE 10-90%, SUCH AS A BATHROOM OR KITCHEN". THE USER WAS SENT CONTROL SOLUTION TO VERIFY ACCURACY OF METER AND STRIPS. WITH THE NEW STRIPS, THE METER READ WITHIN RANGE. HE WAS UNABLE TO OBTAIN A READING WITH THE OLD STRIPS. AT THE TIME OF THE CONTROL SOLUTION TEST, THOSE STRIPS WERE ALREADY EXPIRED BUT THEY MAY HAVE BEEN AFFECTED BY THE BATHROOM HUMIDITY AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758754 DARIO BLOOD GLUCOSE MONITORING SYSTEM SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER NBW LABSTYLE INNOVATIONS LTD. 1021-02 1808231

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization