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

Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459); Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported receiving a bg reading of 77 mg/dl followed by a bg reading of 121 mg/dl from his dario meter.
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, it was determined that the user was using a cartridge of strips that expired in january 2024.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".A replacement of dario's strips was sent to the user to make sure that the dario strips are reading correctly.After the above was received, dario's representative followed up with the user.The user reported that although he received the new cartridge of strips, he didn't open them yet.Instead, the user reported that he opened and tested with a new cartridge of strips that he had at home, that were not expired, and he received bg readings within his normal range.Since the user's bg reading issue was resolved with new strips, therefore, it can be determined that there was misuse of the strips.This complaint is not confirmed.

• 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: 19749386
• Report Number: 3010606081-2024-00043
• Device Sequence Number: 8850433
• Product Code: NBW
• UDI-Device Identifier: 00850065006253
• UDI-Public: 850065006253
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/11/2024

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
• 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: 07/16/2024
• 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 Age: 48 YR
• Patient Sex: Male