BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 19570456 · Received June 19, 2024

    Report

    Report Number
    3010606081-2024-00036
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 4, 2024
    Report Date
    July 3, 2024
    Manufacturer
    LABSTYLE INNOVATIONS LTD.
    Product Code
    NBW
    UDI-DI
    00850065006758
    PMA / PMN Number
    K150817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE BEFORE THE USER CONTACTED DARIO A SECOND TIME. THE USER CONTACTED DARIO AT A LATER DATE. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER REPORTED THAT HE HAS EXPERIENCED INCONSISTENT BG READINGS SINCE HE RECEIVED HIS DARIO METER. IN ADDITION, THE USER ALSO STATED THAT DUE TO THE ABOVE, HE OPENED A NEW STRIPS CARTRIDGE AND IS STILL HAVING INCONSISTENT BG READINGS. THE USER MENTIONED THAT THIS ISSUE HAS OCCURED ACROSS MULTIPLE CARTRIDGES OF STRIPS. A REPLACEMENT OF DARIO'S STRIPS AND DARIO'S METER, WAS SENT TO THE USER TOGETHER WITH A RETURN MATERIAL AUTHORIZATION (RMA) PACKAGE, TO FURTHER INVESTIGATE THIS ISSUE. AFTER THE NEW CARTRIDGE OF STRIPS WAS RECEIVED, A FOLLOW UP ATTEMPT WAS MADE BY THE DARIO REPRESENTATIVE, HOWEVER, NO RESPOND TO DATE. AS OF THIS DATE, THE RMA WAS NOT RECEIVED. IF THE RMA IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE SUBMITTED. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING THE DARIO METER AND STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE. ADDITION FOR THE FOLLOW-UP REPORT: RMA INVESTIGATION TEST RESULTS WITH DARIO'S CONTROL SOLUTION CONCLUDED THAT THE READINGS WERE WITHIN RANGE: LEVEL 1 TEST RESULTS WERE 135 MG/DL, 137 MG/DL, 143 MG/DL, WITHIN THE RANGE OF 105-151 MG/DL. LEVEL 2 TEST RESULTS WERE 231 MG/DL, 245 MG/DL, 247 MG/DL, WITHIN THE RANGE OF 182-261 MG/DL. THE RMA PACKAGE WAS RECEIVED FOR INVESTIGATION ON (B)(6) 2024. THE METER WAS TESTED, AND WAS READING WITHIN RANGE. THEREFORE, IT WAS DETERMINED THAT THIS COMPLAINT IS NOT DUE TO A METER ISSUE. THERE IS NOT ENOUGH INFORMATION REGARDING THE DARIO STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE BEFORE THE USER CONTACTED DARIO A SECOND TIME. THE USER CONTACTED DARIO AT A LATER DATE. WHILE ON THE PHONE WITH DARIO'S REPRESENTATIVE, THE USER REPORTED THAT HE HAS EXPERIENCED INCONSISTENT BG READINGS SINCE HE RECEIVED HIS DARIO METER. IN ADDITION, THE USER ALSO STATED THAT DUE TO THE ABOVE, HE OPENED A NEW STRIPS CARTRIDGE AND IS STILL HAVING INCONSISTENT BG READINGS. THE USER MENTIONED THAT THIS ISSUE HAS OCCURED ACROSS MULTIPLE CARTRIDGES OF STRIPS. A REPLACEMENT OF DARIO'S STRIPS AND DARIO'S METER, WAS SENT TO THE USER TOGETHER WITH A RETURN MATERIAL AUTHORIZATION (RMA) PACKAGE, TO FURTHER INVESTIGATE THIS ISSUE. AFTER THE NEW CARTRIDGE OF STRIPS WAS RECEIVED, A FOLLOW UP ATTEMPT WAS MADE BY THE DARIO REPRESENTATIVE, HOWEVER, NO RESPOND TO DATE. AS OF THIS DATE, THE RMA WAS NOT RECEIVED. IF THE RMA IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE SUBMITTED. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING THE DARIO METER AND STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER STATED THAT SEVERAL DAYS PRIOR TO CONTACTING DARIO, HE TESTED HIS BG LEVEL AND SUSPECTED THAT HIS RESULTS WERE INACCURATE. THE USER STATED THAT HE TESTED HIS BG LEVEL AND THEN IMMEDIATELY TESTED AGAIN AND RECEIVED A 10 MG/DL DIFFERENCE BETWEEN THESE TWO BG TESTS. ON THE MORNING OF (B)(6) PRIOR TO SPEAKING WITH DARIO'S REPRESENTATIVE, THE USER TESTED HIS BG LEVEL AND RECEIVED BG READINGS OF 92 MG/DL, 134 MG/DL AND 165 MG/DL.

    Description of Event or Problem · 0

    ON MAY 19TH, 2024, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER STATED THAT SEVERAL DAYS PRIOR TO CONTACTING DARIO, HE TESTED HIS BG LEVEL AND SUSPECTED THAT HIS RESULTS WERE INACCURATE. THE USER STATED THAT HE TESTED HIS BG LEVEL AND THEN IMMEDIATELY TESTED AGAIN AND RECEIVED A 10 MG/DL DIFFERENCE BETWEEN THESE TWO BG TESTS. ON THE MORNING OF (B)(6), PRIOR TO SPEAKING WITH DARIO'S REPRESENTATIVE, THE USER TESTED HIS BG LEVEL AND RECEIVED BG READINGS OF 92 MG/DL, 134 MG/DL AND 165 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673845 DARIO BLOOD GLUCOSE MONITORING SYSTEM GLUCOMETER NBW LABSTYLE INNOVATIONS LTD. 2401221 00850065006758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other