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); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported receiving the following bg readings: on (b)(6): dario meter - 112 mg/dl vs.Non-dario meter - 146 mg/dl.On (b)(6): dario meter - 129 mg/dl vs.Non-dario meter - 137 mg/dl.On (b)(6): dario meter - 123 mg/dl vs.Non-dario meter - 129 mg/dl on (b)(6): dario meter - 122 mg/dl vs.Non-dario meter - 134 mg/dl.The user added that he received a bg reading of 141 mg/dl at the doctor's office during a scheduled checkup.While on the phone with dario's representative, it was determined that the user was storing his cartridge of strips on the kitchen counter.Dario's user guide states in the section of general precautions: "do not store the meter or test strips in an area where the humidity is outside of the range 10-90%, such as a bathroom or kitchen." a replacement of dario's strips was sent to the user to make sure that the dario strips are reading correctly.Dario's representative instructed the user to test his current strips with the control solution, however due to an application issue, the user was unable to test at that time.As of this date, the user's case is still in progress.If new information is received at a later date, a follow up report will be submitted.There is not enough information available regarding the dario meter, strips, and control solution to investigate.No resolution is available.
Event or Problem Description
On january 22nd, the user contacted dario to report low blood glucose (bg) readings.The user reported testing his dario strips using control solution and receiving results that were out of range for the level 2 control solution test.In addition, the user reported receiving bg readings from his dario meter that were less than the bg readings that he received from his non-dario meter.

• 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: 24410552
• Report Number: 3010606081-2026-00011
• Device Sequence Number: 17611931
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2026
• 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: 65 YR
• Patient Sex: Male