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); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On september 18th, the user contacted dario to report low blood glucose (bg) readings.The user reported receiving from her dario meter two bg readings of 44 mg/dl each compared to a bg reading of 160 mg/dl from the user's previous, non-dario, meter.
Additional Manufacturer Narrative
While on the phone with dario's representative, it was determined that the user was using strips that were not dario test strips.Dario's user guide states in the section test strip precautions: "only use dario test strips.Using other test strips with the dario glucose meter can produce inaccurate results".Following the above the user was instructed to test her bg using dario test strips.The user tested and received a bg reading of 99 mg/dl, which the user reported was similar to the reading that she received from the meter that her doctor had given her.In addition, the user stated that her bg reading was now in normal range for her.Since the user's bg reading issue was resolved when the user tested with dario test strips, therefore, it can be determined that there was misuse of strips.This complaint is not confirmed.

• 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: 23317155
• Report Number: 3010606081-2025-00086
• Device Sequence Number: 14694426
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): N
• 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): 10/16/2025

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
• Device Lot Number: 2203021
• 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: 10/16/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female