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	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On the same day as the user's initial contact, an attempt was made to follow up with the user.In response, the user sent dario an additional email.Based on this email, it was determined that the user was using a non-compatible device.Dario's user guide in section compatible platforms with the dario blood glucose monitoring system directs the users to the full list of compatible devices.Following the user's emails, multiple attempts to follow up with the user were made, with no success.The user later reported via email that his dario meter readings were approximately 80-100 points different from his non-dario meter and indicated that he declined to continue troubleshooting with dario.
Event or Problem Description
On (b)(6), the user contacted dario to report high blood glucose (bg) readings.The user reported receiving a bg reading of 239 mg/dl from his dario meter compared to a bg reading of 115 mg/dl from his 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 (Section G): LABSTYLE INNOVATIONS LTD.; 5 tarshish st.; north industrial park; caesarea, 30798 21; IS 3079821
• MDR Report Key: 24087302
• Report Number: 3010606081-2025-00108
• Device Sequence Number: 12216315
• Product Code: NBW
• UDI-Device Identifier: 00850065006758
• UDI-Public: 850065006758
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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): 01/15/2026

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
• Device Lot Number: 24Z21A1
• 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: 01/15/2026
• Was Device Evaluated by Manufacturer? (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: Male