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

Model Number	1021-04
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/13/2025
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 reported receiving from her dario meter a bg reading of 168 mg/dl compared to a bg reading of 134 mg/dl from her non-dario meter.The user also stated that her shipment of dario meter, test strips and supplies was left on her doorstep in very hot weather conditions.
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported that she has made changes in her daily activity and diet.The user was instructed to open a new strips cartridge in order to test her bg and to contact dario with the results.The user understood the instructions.The user emailed us and reported that she touches the yellow window of the test strip when removing the strips from the cartridge.Dario's user guide states in the section precautions: "do not touch the yellow window of a test strip".It also states in the section general precautions: "do not leave the meter in very hot or cold places.Do not leave it near a heat source (radiator) or in a car in hot or cold weather." 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, dario's representative followed up with the user.The user reported that she tested the dario meter with control solution and a new cartridge of strips, and that the meter read within range for both control solution tests for level 1 and level 2.The user also reported that when using the dario meter, her bg readings are now reading in the normal range for her and are similar to the bg readings that she received from her non-dario meter.The high bg readings were most likely due to the high temperature outside where the strips were left, when the user's dario kit was delivered.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.

• 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: 22794624
• Report Number: 3010606081-2025-00051
• Device Sequence Number: 18303587
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• 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): 08/13/2025

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: 1021-04
• Device Lot Number: 2204211
• 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: 08/13/2025
• 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: 55 YR
• Patient Sex: Female