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

Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On the 12th of june, the user sent an additional email to dario stating that she received in a matter of ten minutes, a bg reading of 168 mg/dl using the meter from the infusion facility, compared to a bg reading of 350 mg/dl that she received from her dario meter.On the 13th of june, dario's representative spoke with the user, who stated that she receives an iv once a week, and that she received bg readings of 138 mg/dl and 168 mg/dl at the facility.The user also stated that she had thrown her dario meter away, and therefore, no troubleshooting steps could be taken.There is not enough information available to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On june 11th, the user contacted dario to report high blood glucose (bg) readings.The user, who stated that she has been using the dario meter for many years, reported receiving a bg reading of 350 mg/dl from her dario meter after returning home from the facility where she received an infusion for her diabetes.The user reported receiving a bg reading of 138 mg/dl at the facility after receiving her infusion.

• 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: 22466648
• Report Number: 3010606081-2025-00038
• Device Sequence Number: 12790416
• Product Code: NBW
• UDI-Device Identifier: 00850065006161
• UDI-Public: 850065006161
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 07/10/2025

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
• 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: 07/10/2025
• 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: 78 YR
• Patient Sex: Female