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	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, it was determined that the user was storing her strips in the bathroom.Dario's user guide states in the section of 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." 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.After the above was received, the user contacted dario and reported that the new test strips were reading within range from the control solution test.Since the user's bg reading issue was resolved with new strips, therefore, it can be determined that there was misuse of the strips.This complaint is not confirmed.
Event or Problem Description
On october 7th, the user contacted dario to report high blood glucose (bg) readings.The user reported receiving a bg reading of 222 mg/dl from her dario meter compared to a bg reading of 114 mg/dl from her non-dario meter.

• 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: 23488077
• Report Number: 3010606081-2025-00095
• Device Sequence Number: 10499648
• Product Code: NBW
• UDI-Device Identifier: 00850065006741
• UDI-Public: 850065006741
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/06/2025
• 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 Age: 61 YR
• Patient Sex: Female