BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 17839363 · Received September 28, 2023

    Report

    Report Number
    3010606081-2023-00050
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 30, 2023
    Report Date
    August 30, 2023
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    PMA / PMN Number
    K150817
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING 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 A MONTH 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". WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER REPORTED THAT HE PURCHASED CONTROL SOLUTION AND TESTED WITH HIS OLD STRIPS AND NEW STRIPS. THE USER REPORTED THAT HIS OLD STRIPS TESTED OUT OF RANGE IN THE CONTROL SOLUTION TEST. HOWEVER, THE USER'S DARIO METER READ WITHIN RANGE FOR THE NEW CARTRIDGE OF STRIPS, FOR BOTH CONTROL SOLUTION LEVELS: CONTROL SOLUTION LEVEL 1 TEST RESULTS WAS 142 MG/DL (RANGE 105-151 MG/DL) CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 241 MG/DL (RANGE 181-260 MG/DL) THE USER HAD NOT YET TESTED HIS BG USING THE NEW CARTRIDGE OF STRIPS. THE USER REPORTED THAT SINCE THE CONTROL SOLUTION TEST FELL WITHIN RANGE, HE WILL CONTINUE TO TEST HIS BG LEVEL WITH THE DARIO METER AND WILL CONTACT DARIO SHOULD HE HAVE ANY ISSUES. THE HIGH BG READINGS MAY HAVE BEEN DUE TO MISUSE OF THE STRIPS. THERE IS NOT ENOUGH INFORMATION REGARDING THE METER AND OLD STRIPS AVAILABLE TO FURTHER INVESTIGATE THIS CASE. THEREFORE, NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON AUGUST 30TH, THE USER'S WIFE CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER'S WIFE REPORTED THAT ALTHOUGH THE USER'S BG READINGS WERE INITIALLY IN RANGE FOR HIM, THE USER RECENTLY BEGAN RECEIVING HIGH BG READINGS FROM HIS DARIO METER. THE USER'S WIFE REPORTED THAT TWO DAYS PRIOR TO CONTACTING DARIO, THE USER WENT TO THE HOSPITAL TO SEE HIS DOCTOR, WHERE HIS BG LEVEL WAS TESTED AND FOUND TO READ 91 MG/DL FROM THE DOCTOR'S METER COMPARED TO A BG READING OF 214 MG/DL FROM THE USER'S DARIO METER. DUE TO THIS DIFFERENCE IN READINGS, THE USER REPORTED THAT HE PURCHASED A NON-DARIO METER. THE USER TESTED IN THE MORNING WITH THE NON-DARIO METER AND RECEIVED A BG READING OF 103 MG/DL COMPARED TO A BG READING OF 251 MG/DL WITH THE USER'S DARIO METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2087411 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other| H