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

Model Number	1021-06
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On february 11th, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported receiving bg readings from her dario meter that were significantly different than her other glucometer.
Additional Manufacturer Narrative
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, an attempt to follow up with the user was made, however, no response has been received to date.There is not enough information available to further 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.; innovations ltd.; 5 tarshish st; north industrial park, caesarea 30798 21; IS 3079821
• Manufacturer Contact: 5 tarshish st.; north industrial park; caesarea, 30798-2
• MDR Report Key: 21562873
• Report Number: 3010606081-2025-00009
• Device Sequence Number: 9170485
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): Y
• 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): 03/10/2025

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
• 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: 03/10/2025
• 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 Sex: Female