BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 8300458 · Received February 3, 2019

    Report

    Report Number
    3010606081-2019-00001
    Event Type
    Injury
    Date Received
    February 3, 2019
    Date of Event
    January 3, 2019
    Report Date
    February 3, 2019
    Manufacturer
    LABSTYLE INNOVATIONS LTD
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE READINGS. SHE CONSULTED HER PHYSICIAN - AT HIS CLINIC HER BLOOD GLUCOSE READ 268 AND DARIO METER READ 387. WHEN TALKING TO THE USER, SHE STATED THE STRIPS WERE KEPT IN THE KITCHEN - IT IS INSTRUCTED IN DARIO USER GUIDE UNDER 'GENERAL PRECAUTIONS': "DO NOT STORE THE 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 TRAINED ON THE MAINTENANCE OF STRIPS AND INSTRUCTED TO OPEN A NEW CARTRIDGE. THE ISSUE WAS RESOLVED WITH NEW STRIPS. NO DEVICE PROBLEM DETECTED, NOT ENOUGH INFORMATION REGARDING THE OLD STRIPS TO INVESTIGATE. THE COMPLAINT FAILURE MODE WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93401 DARIO BLOOD GLUCOSE MONITORING SYSTEM NBW NBW LABSTYLE INNOVATIONS LTD 1021-04 1805161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other