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

Lot Number	2104301
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While on the phone with dario's representative, it was determined that the cartridge of strips that the user was testing with were newly opened, however the user stated that he has stopped using the dario meter.A replacement of dario's control solution was sent to the user to make sure that the dario strips are reading correctly.After the new dario control solution were received, dario's representative followed up with the user.While on the follow up phone call with dario's representative, it was determined that the user was using a cartridge of strips that had expired in november 2023, and therefore the control solution test could not be completed.Dario's user guide states in the section factors that may lead to inaccurate results: "the test strip is expired." and in the test strip precautions section: "check the "use by" date on the test strip cartridge.Do not use the test strips after that date" due to the above, dario's representative sent the user a new cartridge of strips to perform the control solution test and bg with.As of this date, the replacement was not yet received and the user's case is still in progress.The high bg readings may have been due to misuse of the strips.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 august 7th, the user contacted dario to report low blood glucose (bg) readings.The user reported that a couple of months ago, he began receiving low bg readings from his dario meter compared to the bg readings from his dexcom meter and his other non-dario meter.Due to the above, the user reported that he brought his dario meter with him to the doctor in order to compare his bg readings with the doctor's 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: 20155897
• Report Number: 3010606081-2024-00054
• Device Sequence Number: 17202711
• Product Code: NBW
• UDI-Device Identifier: 00850065006253
• UDI-Public: 850065006253
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 09/06/2024

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 Lot Number: 2104301
• 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: 09/06/2024
• 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 Sex: Male