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

Model Number	1021-04
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While troubleshooting on the phone with dario's representative, it was determined that the user had no additional strips to test with.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, dario's representative followed up with the user, however the user hung up the phone and didn't speak with dario's representative.An additional email was sent to the user however no response has been received to date.There is not enough information available to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On november 29th, the user contacted dario to report insonsistent blood glucose (bg) readings.The user reported receiving from her dario meter consecutive bg readings of 122 mg/dl, 85 mg/dl, and 108 mg/dl using the same finger and drop of blood.The user stated that these readings did not align with how she felt.The user reported that several days later she tested using her dario meter with the same finger and drop of blood and received a bg reading of 131 mg/dl, followed by a reading of 114 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: 23903660
• Report Number: 3010606081-2025-00104
• Device Sequence Number: 18041403
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 12/28/2025

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
• 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: 12/28/2025
• 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 Sex: Female