MAUDE Adverse Event Report: LABSTYLE INNOVATIONS LTD DARIO BLOOD GLUCOSE MONITORING SYSTEM; GLUCOMETER

Model Number	1021-06
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), the user contacted dario to report high blood glucose (bg) readings.The user stated that since on (b)(6) 2025, her bg readings were in the range of 400 mg/dl to 500 mg/dl using her dario meter.The user also reported that due to the above, the user called her doctor, who doubled her dosage of metformin.The user added that she purchased a non-dario meter, which gave her bg readings in the 130 mg/dl to 150 mg/dl range.The user stated that she informed her doctor, who readjusted her metformin dosage back to the original dosage.
Additional Manufacturer Narrative
While on the phone with dario's representative, an attempt to troubleshoot with the user was made, however the user refused and simply requested to cancel her membership.There is not enough information available regarding the dario meter and strips to investigate.No resolution is available.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: GLUCOMETER
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD; 5 tarshish st; north industrial park; caesarea, 30798 21; IS 3079821
• Manufacturer Contact: 5 tarshish st; north industrial park; caesarea, 30798-21
• MDR Report Key: 23278400
• Report Number: 3010606081-2025-00084
• Device Sequence Number: 20210282
• Product Code: NBW
• UDI-Device Identifier: 00850065006741
• UDI-Public: 850065006741
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1021-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female