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	07/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported that she received a bg reading of 200 mg/dl from her dario meter compared to a bg reading of 106 mg/dl from her non-dario meter, which the user stated was a normal bg reading for her.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 new dario strips and control solution were received, dario's representative followed up with the user.The user reported that she tested her bg with the new cartridge of strips and received readings that were in range for her.The high bg readings may have been due to misuse of the strips.There is not enough information regarding the meter and old strips available to further investigate this case.Therefore, no resolution is available.
Event or Problem Description
On july 6th, the user contacted dario to report inconsistent and high blood glucose (bg) readings.The user reported receiving from her dario meter bg readings of 119 mg/dl and 130 mg/dl one minute later, compared to bg readings of 108 mg/dl and 111 mg/dl four minutes later from her non-dario meter.

• 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: 22725770
• Report Number: 3010606081-2025-00046
• Device Sequence Number: 15739188
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• 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): 08/06/2025

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
• 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: 08/06/2025
• 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: 41 YR
• Patient Sex: Female