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	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On may 23rd the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported receiving bg readings that according to her, are inaccurate, including bg readings that are greatly varying when testing consecutively.The user stated that despite taking troubleshooting steps, the inconsistent bg readings persist.
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported receiving with a new strips cartridge bg readings of 130 mg/dl, 140 mg/dl, 150 mg/dl, and 160 mg/dl, all within several minutes.Due to the above, a replacement of dario's meter was sent to the user.An attempt to follow up with the user was made, however, no response has been received to date.There is not enough information regarding the meter and old strips 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.; 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: 22309856
• Report Number: 3010606081-2025-00036
• Device Sequence Number: 7937441
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 06/23/2025

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: 06/23/2025
• 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