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

Lot Number	2102011
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); Insufficient Information (4580)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During troubleshooting on the phone with dario's representative, the user stated that she received from her dario meter a low bg reading of 79 mg/dl and a high bg reading of 402 mg/dl, when compared to bg readings of 130 mg/dl and 140 mg/dl from her two other non-dario meters.While on the phone with dario's representative, the user stated that several hours after testing, she retested and received a bg reading of 89 mg/dl.Due to this reading, the user stated that she ate something in order to raise her bg level.The user reported that she has begun to test three to four times a day, due to the inconsistent bg readings that she has been receiving.The user also mentioned that she did not experience any symptoms of low or high blood glucose levels that correlated with the bg readings that she received.Due to the above, a replacement of dario's strips and control solution was sent to the user to make sure that the dario strips and meter are reading correctly, and to ensure proper technique.After the above was received, multiple attempts to follow up with the user were made, however, no response has been received to date.
Event or Problem Description
On (b)(6) 2024, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported that she received from her dario meter several low bg readings followed by a high bg reading.Due to the above, the user stated that she decided to test her bg level using another two non-dario meters.

• 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: 19604347
• Report Number: 3010606081-2024-00037
• Device Sequence Number: 7279661
• Product Code: NBW
• UDI-Device Identifier: 00850065006406
• UDI-Public: 0850065006406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/25/2024

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: 2102011
• 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: 06/25/2024
• 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: Female