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

Lot Number 2311061

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem Hyperglycemia (1905)

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

During troubleshooting on the phone with dario's representative, it was determined that the user was using a cartridge of strips that was open since mid-january and was therefore expired.Dario's user guide states in the section precautions: "do not use a test strip expired 1 month from opening.Discard the cartridge 1 month after opening".In addition, it was also determined that the user was storing her dario strips in a ziplock bag instead of inside the dario strips cartridge which is designated for that purpose.Dario's user guide states in the section precautions: "a test strip is sensitive to humidity.Therefore, you should keep a test strip in the specified cartridge, and after pulling out the test strip from its cartridge, close the test strip cartridge cap immediately." 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, an attempt to follow up with the user was made, however, no response has been received to date.The high bg readings may have been due to misuse of the strips.There is not enough information regarding the meter and old strips available to further investigate this case.Therefore, no resolution is available.

Event Description

On (b)(6) 2024, the user contacted dario to report high blood glucose (bg) readings.The user reported receiving a bg reading of 558 mg/dl from her dario meter compared to a bg reading of 158 mg/dl at her doctor's office with the doctor's meter.The user went to her doctor for a regular appointment and not due to her high bg reading.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: 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: 18966413
• MDR Text Key: 338447584
• Report Number: 3010606081-2024-00018
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 2311061
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female