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	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On august 12th, the user contacted dario to report high blood glucose (bg) readings.The user reported testing multiple times and receiving high bg readings from his dario meter when compared to his non-dario meter.
Additional Manufacturer Narrative
While on the phone with dario's representative, it was determined that the user's bg readings from the dario meter were 15 mg/dl to 20 mg/dl higher than his non-dario meter.Due to the above, 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 who reported that he tested using the new cartridge of strips and that his readings were in range.In addition, the user also reported that he tested his bg with the new strips and received a reading of 145 mg/dl.The user stated that his normal bg range is 115 mg/dl to 125 mg/dl, and that he received similar bg readings to this range from his non-dario meter.The user informed dario's representative that he has an upcoming doctor's appointment where he will take both of his meters and compare bg readings there.On september 11th, dario's representative spoke to the user, who reported that today he received from his dario meter a bg reading of 166 mg/dl, compared to a bg reading of 116 mg/dl from his non-dario meter.The user also reported receiving on september 6th a bg reading of 120 mg/dl from his dario meter compared to a bg reading of 115 mg/dl from his non-dario meter followed by a bg reading of 123 mg/dl from his dario meter compared to a bg reading of 108 mg/dl from his non-dario meter.Due to the difference in readings above, a replacement of dario's meter, was sent to the user together with a return material authorization (rma) package, to further investigate this issue.If the rma or any additional information is received at a later date, a follow up report will be submitted.There is not enough information available regarding the dario meter and strips to investigate.No resolution is available.
Additional Manufacturer Narrative
While on the phone with dario's representative, it was determined that the user's bg readings from the dario meter were 15 mg/dl to 20 mg/dl higher than his non-dario meter.Due to the above, 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 who reported that he tested using the new cartridge of strips and that his readings were in range.In addition, the user also reported that he tested his bg with the new strips and received a reading of 145 mg/dl.The user stated that his normal bg range is 115 mg/dl to 125 mg/dl, and that he received similar bg readings to this range from his non-dario meter.The user informed dario's representative that he has an upcoming doctor's appointment where he will take both of his meters and compare bg readings there.On (b)(6), dario's representative spoke to the user, who reported that today he received from his dario meter a bg reading of 166 mg/dl, compared to a bg reading of 116 mg/dl from his non-dario meter.The user also reported receiving on (b)(6) a bg reading of 120 mg/dl from his dario meter compared to a bg reading of 115 mg/dl from his non-dario meter followed by a bg reading of 123 mg/dl from his dario meter compared to a bg reading of 108 mg/dl from his non-dario meter.Due to the difference in readings above, a replacement of dario's meter, was sent to the user together with a return material authorization (rma) package, to further investigate this issue.If the rma or any additional information is received at a later date, a follow up report will be submitted.There is not enough information available regarding the dario meter and strips to investigate.No resolution is available.Addition for the follow-up report: rma investigation test results with dario's control solution concluded that the readings were within range: level 1 test results were 124 mg/dl, 126 mg/dl, 128 mg/dl, within the range of 108-155 mg/dl.Level 2 test results were 216 mg/dl, 218 mg/dl, 219 mg/dl, within the range of 186-267 mg/dl.The rma package was received for investigation on october 6th, 2025.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.
Event or Problem Description
On (b)(6), the user contacted dario to report high blood glucose (bg) readings.The user reported testing multiple times and receiving high bg readings from his dario meter when compared to 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: 23037196
• Report Number: 3010606081-2025-00068
• Device Sequence Number: 18505360
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 11/04/2025

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
• Device Lot Number: 2203021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/04/2025
• 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: 70 YR
• Patient Sex: Male