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

Model Number	1021-06
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On december 7th, the user contacted dario to report low blood glucose (bg) readings.The user reported performing multiple, consecutive bg tests with two other non-dario meters, which gave her different readings.The used also mentioned that she stopped using the dario meter due to the low bg readings she received from it.
Additional Manufacturer Narrative
The user contacted dario the following day and reported testing her bg since she felt like it was high, however her dario meter gave her a low bg reading.The user also stated that she thinks her strips are expired and has discontinued the user of the dario meter.While on the phone with dario's representative, it was determined that the user received bg readings from her dario meter that were between 10 mg/dl and 15 mg/dl lower than her other non-dario meter.The user stated that she used the same drop of blood from the same finger when testing her bg.It was also determined that the user's cartridge of strips had been open for longer than thirty days and were therefore, expired.Dario's user guide states in the section precautions: "do not use a test strip expired 1 month from opening.Discard the cartridge 1 month after opening".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, dario's representative followed up with the user, who confirmed that she had received the control solution and new cartridge of strips, however was unable to test with dario's representative at that time.At a later date, dario's representative made another attempt to follow up with the user, with no response.The low 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.

• 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: 23994142
• Report Number: 3010606081-2025-00106
• Device Sequence Number: 13395862
• Product Code: NBW
• UDI-Device Identifier: 00850065006741
• UDI-Public: 850065006741
• Combination Product (Y/N): N
• 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): 01/07/2026

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: 1021-06
• Device Lot Number: 2403041
• 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: 01/07/2026
• 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 Age: 62 YR
• Patient Sex: Female