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	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On april 23rd, the user contacted dario to report low blood glucose (bg) readings.The user reported receiving from his dario meter an ea1c of 5.4% compared to an a1c of 6.7% from his blood work.
Additional Manufacturer Narrative
While on the phone with dario's representative, the user stated that he tests his bg three times a day consistently.The user confirmed that the blood work he had was for a routine visit, not due to the dario readings, and that he is currently on ozempic and tresiba.During troubleshooting on the phone with dario's representative, the user stated that he carries the test strips with him frequently and places it on his bedside.In addition, it was also determined that the user was using alcohol/wipes before testing.Dario's user guide states in the section factors that interfere with blood glucose testing: "alcohol can affect test results".Dario's representative educated the user regarding the interference of using alcohol/wipes with test results.A control solution was sent to the user to make sure that the dario strips are reading correctly, and to ensure proper technique.There is not enough information available to 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: 25262765
• Report Number: 3010606081-2026-00040
• Device Sequence Number: 13389782
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/22/2026

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
• 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: 05/22/2026
• 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 Sex: Male