BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 20620190 · Received November 6, 2024

    Report

    Report Number
    3010606081-2024-00064
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 6, 2024
    Report Date
    November 6, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006154
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER WAS USING A CARTRIDGE OF STRIPS THAT WAS OPEN FOR MORE THAN 30 DAYS AND WAS THEREFORE EXPIRED. DARIO'S USER GUIDE STATES IN THE SECTION PRECAUTIONS: "DO NOT USE A TEST STRIP EXPIRED 1 MONTH FROM OPENING. DISCARD THE CARTRIDGE 1 MONTH AFTER OPENING". A REPLACEMENT OF DARIO'S STRIPS AND CONTROL SOLUTION WAS SENT TO THE USER TO MAKE SURE THAT THE DARIO STRIPS ARE READING CORRECTLY, AND TO ENSURE PROPER TECHNIQUE. DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER MENTIONED THAT AFTER HE HAD TESTED WITH HIS NON-DARIO METER AND RECEIVED A BG READING OF 102 MG/DL HE THEN TESTED HIS BG WITH HIS SECOND DARIO METER, AND ALSO RECEIVED A READING OF 102 MG/DL. DUE TO THE DIFFERENCE IN READINGS ABOVE, A REPLACEMENT OF DARIO'S METER WAS SENT TO THE USER TOGETHER WITH A RETURN MATERIAL AUTHORIZATION (RMA) PACKAGE, TO FURTHER INVESTIGATE THIS ISSUE. THE RMA PACKAGE WAS RECEIVED FOR INVESTIGATION ON OCTOBER 30TH, 2024. THE METER WAS TESTED AND WAS READING WITHIN RANGE. RMA INVESTIGATION TEST RESULTS WITH DARIO'S CONTROL SOLUTION CONCLUDED THAT THE READINGS WERE WITHIN RANGE: LEVEL 1 TEST RESULTS WERE 133 MG/DL, 133 MG/DL, 133 MG/DL, WITHIN THE RANGE OF 109-157 MG/DL. LEVEL 2 TEST RESULTS WERE 223 MG/DL, 226 MG/DL, 227 MG/DL, WITHIN THE RANGE OF 182-261 MG/DL. THEREFORE, IT WAS DETERMINED THAT THIS COMPLAINT IS NOT DUE TO A METER ISSUE. AFTER THE NEW REPLACEMENT OF DARIO'S METER WAS RECEIVED BY THE USER, AN ATTEMPT WAS MADE TO FOLLOW UP WITH THE USER IN ORDER TO TEST THE USER'S BG READINGS WITH THE NEW DARIO METER, CARTRIDGE OF STRIPS AND CONTROL SOLUTION, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. THE HIGH BG READINGS MAY HAVE BEEN DUE TO MISUSE OF THE STRIPS. THERE IS NOT ENOUGH INFORMATION REGARDING THE OLD STRIPS AVAILABLE TO FURTHER INVESTIGATE THIS CASE. NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON OCTOBER 6TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT ON THE MORNING OF OCTOBER 6TH, HE RECEIVED A BG READING OF 250 MG/DL FROM HIS DARIO METER. THE USER STATED THAT HE RETESTED HIS BG LEVEL 45 MINUTES LATER AND RECEIVED A BG READING OF 393 MG/DL. DUE TO THE ABOVE THE USER TESTED HIS BG LEVEL WITH A NON-DARIO METER AND RECEIVED A READING OF 102 MG/D, WHICH THE USER STATED WAS IN NORMAL RANGE FOR HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997496 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. 1021-04 2204211 00850065006154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other