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

Model Number	1021-04
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported that his bg readings are 10 mg/dl to 20 mg/dl different on the same dario meter when he tests consecutively.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.As of this date, the rma was not received.If the rma 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.
Event or Problem Description
On may 21st, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported that his dario meter was not functioning properly.
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported that his bg readings are 10 mg/dl to 20 mg/dl different on the same dario meter when he tests consecutively.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.As of this date, the rma was not received.If the rma 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 126 mg/dl, 125 mg/dl, 125 mg/dl, within the range of 108-155 mg/dl.Level 2 test results were 207 mg/dl, 211 mg/dl, 213 mg/dl, within the range of 186-267 mg/dl.The rma package was received for investigation on june 19th, 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 may 21st, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported that his dario meter was not functioning properly.

• 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: 22293752
• Report Number: 3010606081-2025-00035
• Device Sequence Number: 18222468
• Product Code: NBW
• UDI-Device Identifier: 00850065006154
• UDI-Public: 850065006154
• 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,Followup
• Report Date (Section B): 07/29/2025

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: 1021-04
• Device Lot Number: 2204211
• 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: 06/19/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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: 67 YR
• Patient Sex: Male