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); High Readings (2459)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), the user contacted dario to report high blood glucose (bg) readings.The user reported that his recent a1c result of 6.9% does not align with his bg readings of more than 200 mg/dl that he has been receiving from his dario meter.The user also stated that he used control solution multiple times, which indicated that his dario strips are reading within range.Despite the control solution results, the user stated that he still suspected that his bg readings were inaccurate, and therefore was recommended by his provider to purchase and use a non-dario meter.The user reported that the bg readings that he receives from his dario meter are consistently 65 mg/dl higher than the bg readings that he receives from his non-dario meter.
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user stated that his non-dario meter gave him bg readings in the 100 mg/dl range compared to bg readings in the 200 mg/dl range from his dario meter, which the user stated is not his normal bg range.During this phone call, it was determined that the user was using a cartridge of strips that was open for 2 months and was 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".While on the phone with dario's representative, the user mentioned that he opened a new cartridge of strips on (b)(6), and he is receiving bg readings that are within range.Since the user's bg reading issue was resolved with new strips, therefore, it can be determined that there was misuse of the strips.This complaint is not confirmed.

• 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: 23666094
• Report Number: 3010606081-2025-00100
• Device Sequence Number: 16023009
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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): 11/27/2025

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: 11/27/2025
• 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 Age: 50 YR
• Patient Sex: Male