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	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6), dario's representative contacted the user in order to follow up regarding the replacement meter that the user recently received.The user reported a difference in the range of 15 mg/dl to 20 mg/dl in her bg readings when performing consecutive tests with her dario meter.
Additional Manufacturer Narrative
While on the phone with dario's representative, it was determined that the user was transferring new dario strips into the old dario strips cartridge.Dario's user guide states in the section storage and handling: "do not transfer test strips from one cartridge to another".A replacement of dario's strips was sent to the user.After the above was received, dario's representative followed up with the user, who stated that she is still receiving inconsistent readings and reported receiving a reading of 365 mg/dl followed by a second reading of 270 mg/dl using her replacement of dario's strips and meter.Due to the 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.After the replacement was received, dario's representative followed up with the user who reported that she received a bg reading of 404 mg/dl followed by a reading of 289 mg/dl.The user then requested a follow up call later that day from dario's representative in order to perform a control solution test.Dario's representative followed up with the user later that day and 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 147 mg/dl (range 110-159 mg/dl) control solution level 2 test results was 234 mg/dl (range 192-277 mg/dl) during this troubleshooting, it was also determined that the user was storing her cartridge of strips in the kitchen.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." the user reported that she performs three bg tests and uses the middle test result in order to determine how much insulin to administer.The user also stated that these inconsistent bg readings also occur with her non-dario meters that she has, including her cgm device.On (b)(6), an additional attempt to follow up with the user was made, however, no response has been received to date.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.

• 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: 23301955
• Report Number: 3010606081-2025-00085
• Device Sequence Number: 4889894
• Product Code: NBW
• UDI-Device Identifier: 00850065006253
• UDI-Public: 850065006253
• 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
• Report Date (Section B): 10/15/2025

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: 2204214
• 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: 10/15/2025
• 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: 43 YR
• Patient Sex: Female