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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), the user contacted dario to report inconsistent and high blood glucose (bg) readings.The user reported receiving from her dario meter inconsistent bg readings towards the end of thirty days of usage.The user also reported that she compares the bg readings that she receives from her dario meter with a non-dario meter, testing at the same time, and using the same drop of blood.The user stated that after opening a new cartridge of strips, the user receives a 10 mg/dl difference in bg readings between her dario meter and her non-dario meter, however several weeks later, the user receives bg readings with a 50 mg/dl to 100 mg/dl difference between her two meters.The user further reported that her a1c results are more aligned with the bg readings that she received from her non-dario meter, which are lower than the bg readings that she receives from her dario meter.
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported that when the issue occured, the user received a bg reading of 125 mg/dl from her dario meter compared to a bg reading of 150 mg/dl from her non-dario meter.The user also reported that on (b)(6) 2025, she received a bg reading of 267 mg/dl from her dario meter compared to a bg reading of 147 mg/dl from her non-dario meter.Due to the above, 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, an attempt to follow up with the user was made, however, no response has been received to date.There is not enough information regarding the meter and old strips available to further investigate this case.Therefore, no resolution is available.

• 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: 24324348
• Report Number: 3010606081-2026-00005
• Device Sequence Number: 21201209
• 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): 02/12/2026

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: 1021-04
• 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: 02/12/2026
• 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: 68 YR
• Patient Sex: Female