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	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user reported received the following bg readings on the following dates: using the dario meter: (b)(6) 2026 - 76 mg/dl, (b)(6) 2026 - 88 mg/dl, (b)(6) 2026 - 90 mg/dl.Using the user's non-dario meter: (b)(6) 2026 - 122 mg/dl, (b)(6) 2026 - 121 mg/dl, (b)(6) 2026 - 115 mg/dl.Following the information that the user provided above, the user opened a new cartridge of strips, tested his bg and received from his dario meter a reading of 109 mg/dl compared to a bg reading of 136 mg/dl from his non-dario meter.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 new dario strips and control solution were received, dario's representative followed up with the user.The user's dario meter was tested with control solution and a new cartridge of strips: the meter read within range for both tests.Control solution level 1 test results was 113 mg/dl (range 104-149 mg/dl).Control solution level 2 test results was 194 mg/dl (range 187-269 mg/dl).Dario's representative followed up with the user one week later.The user reported that his bg readings are now in the mid 90 mg/dl range, which is in normal range for him.The user's issue was resolved with the new strips.There is not enough information regarding the old dario strips to investigate.
Event or Problem Description
On february 17th, the user contacted dario to report low blood glucose (bg) readings.The user reported receiving bg readings from his dario meter that were 25 mg/dl to 30 mg/dl lower than his previous bg readings.The user also reported that he recently had lab work done, where he received a bg reading of 109 mg/dl and an a1c of 5.8%.The user stated that on that same day of receiving the blood work, he received from his dario meter a bg reading of 82 mg/dl.Due to the above, the user stated that his doctor advised him to follow up on his bg readings with the 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: 24601691
• Report Number: 3010606081-2026-00018
• Device Sequence Number: 8384496
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): Y
• 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): 03/15/2026

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: 2203021
• 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: 03/15/2026
• 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: 63 YR
• Patient Sex: Male