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); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user reported that he was at the hospital for a routine endoscopy.The user also reported that due to him having diabetes, his bg was tested prior to the procedure.During troubleshooting on the phone with dario's representative, the user reported that the dario strip cartridge cap had been left open and was not closed properly.Due to the above, the strips were exposed for too long and may have become faulty.The high bg readings may have been due to misuse of the strips.Dario's user guide states in the section storage and handling: "after pulling out the test strip from its cartridge, seal the cap of the cartridge tightly to protect test strips." the user reported that he opened and tested with a new cartridge of strips and his bg readings have been in normal range for him.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 april 20th, the user contacted dario to report high blood glucose (bg) readings.The user reported receiving from his dario meter a bg reading of 156 mg/dl.

• 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: 25230282
• Report Number: 3010606081-2026-00038
• Device Sequence Number: 5129913
• Product Code: NBW
• UDI-Device Identifier: 00850065006758
• UDI-Public: 850065006758
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/20/2026

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: 05/20/2026
• 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