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	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported that his bg readings had been in the 180 mg/dl range for the past few days.Due to the user's high readings, the user stated that he discarded his cartridge of strips and opened a new cartridge of strips, which he reported gave him a normal range of bg readings for him.The user also stated that he has not been following an optimal diet lately, which he believes may have contributed to his high bg readings.The user reported that his morning bg readings are in the 120 mg/dl to 140 mg/dl range, but recently have been higher.In addition, the user reported that his post lunch bg readings are approximately 110 mg/dl but are sometimes as low as 85 mg/dl.While on the phone with dario's representative, it was determined that the user was storing his strip cartridges in the kitchen.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." in addition, the customer mentioned that he had previously glued the adapter (metal part) to the dongle, which could affect the bg results.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 august 27th, the user contacted dario to report high blood glucose (bg) readings.The user reported receiving from his dario meter high bg readings after opening his strips cartridge seven days prior.The user stated that he opened and tested with a new cartridge of strips, and his bg readings were in normal range for him.

• 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: 23096181
• Report Number: 3010606081-2025-00075
• Device Sequence Number: 12916044
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 09/19/2025

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
• 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: 09/19/2025
• 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: 70 YR
• Patient Sex: Male