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	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, the user reported that his dario meter always reads 20 mg/dl or more than his non-dario meter.The user also stated that he already received a new cartridge of strips and replacement meter, however his issue persists.The user reported that he ordered new strips and control solution for his non-dario meter and once it is received, he will perform another comparison with his dario meter.In addition, the user also mentioned that he has an upcoming yearly checkup with his doctor where he will test his dario meter against the doctor's meter.As of this date, this case is still in progress, as the user requested a follow up from dario after his doctor's appointment.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 and strips to investigate.No resolution is available.
Event or Problem Description
On october 7th, the user contacted dario to report inconsistent and high blood glucose (bg) readings.The user reported the following bg reading comparisons between the user's non-dario meter and his dario meter, respectively: 102 mg/dl vs.116 mg/dl, 109 mg/dl vs.127 mg/dl, 125 mg/dl vs.188 mg/dl, 114 mg/dl vs.154 mg/dl, 130 mg/dl vs.164 mg/dl, 109 mg/dl vs.130 mg/dl, 87 mg/dl vs.99 mg/dl, 106 mg/dl vs.132 mg/dl, 109 mg/dl vs.126 mg/dl, 101 mg/dl vs.128 mg/dl, 141 mg/dl vs.177 mg/dl, and 119 mg/dl vs.137 mg/dl.The user stated that he was using the same drop of blood and that the readings were taken consecutively.

• 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: 23491100
• Report Number: 3010606081-2025-00096
• Device Sequence Number: 8625765
• Product Code: NBW
• UDI-Device Identifier: 00850065006390
• UDI-Public: 850065006390
• 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
• Report Date (Section B): 11/06/2025

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: 11/06/2025
• 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: 70 YR
• Patient Sex: Male