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	Hypoglycemia (1912)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On february 19th, the user contacted dario to report high blood glucose (bg) readings.The user, who is a nurse, reported receiving bg readings from her dario meter that were 14 mg/dl to 15 mg/dl higher than her non-dario meter.The user reported that after feeling symptomatic for hypoglycemia, she tested her bg using the dario meter and received readings in normal range, while receiving bg readings in the hypoglycemic range from her non-dario meter.The user requested that control solution be sent to her.
Additional Manufacturer Narrative
Following the user's request, control solution was sent to the user to make sure that the dario strips are reading correctly, and to ensure proper technique.The following day, dario's representative followed up with the user to troubleshoot and the user reported receiving a bg reading of 111 mg/dl from her dario meter compared to a reading of 89 mg/dl from her non-dario meter.After the control solution was received, multiple attempts to follow up with the user were made, however, no response has been received to date.Due to a lancing mechanism issue with the user's dario meter, a replacement of dario's meter, was sent to the user together with a return material authorization (rma) package, to further investigate this issue.The meter was also investigated for the user's reading issue.The rma package was received for investigation on march 10th, 2026.The meter was tested, and was reading within range.Therefore, it was determined that this complaint is not due to a meter issue.There is not enough information regarding the dario strips to investigate.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: 24630286
• Report Number: 3010606081-2026-00019
• Device Sequence Number: 9015324
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• Combination Product (Y/N): N
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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
• Device Lot Number: 2204211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 50 YR
• Patient Sex: Female