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	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported that he opened a new cartridge of strips with a different lot number and his issue of inconsistent bg readings persists.The user stated that he was driving and could not troubleshoot at that time.Additional attempts to follow up with the user were 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.
Event or Problem Description
On march 5th, the user contacted dario to report inconsistent blood glucose (bg) readings.The user stated that five days prior, his bg readings on his dario meter changed by 30 mg/dl to 40 mg/dl without the user having changed his diet or exercise.The user also reported that he perfomed consecutive bg tests sixty seconds apart using the same finger prick and he received bg readings that were 10 mg/dl to 15 mg/dl less.Furthermore, the user also stated that he performed these bg tests three times in the past two days and received a bg reading of 159 mg/dl on the first test and 129 mg/dl on the third test.

• 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: 24744434
• Report Number: 3010606081-2026-00022
• Device Sequence Number: 8780428
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 03/31/2026

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: 03/31/2026
• 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: Male