MAUDE Adverse Event Report: LABSTYLE INNOVATIONS LTD. DARIO BLOOD GLUCOSE MONITORING SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number 1021-02

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Shock, Insulin (2264)

Event Date 12/22/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 the user's daughter reported to dario that her mother had received medical treatment for diabetic coma that occured on (b)(6) 2017.The daughter reported her mother's meter demonstrated elevated blood glucose readings for a few weeks prior to this event and her endocrinologist adjusted her insulin regimen as a result.She reported that on (b)(6) 2017 her mother's dario meter read 16mmol and she took the new dosage of insulin.She indicated that her mother's blood glucose was probably around 8mmol.She notes that this led to hypoglycemia and diabetic coma to which she was treated by paramedics with intravenous glucose.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, israel 30889 00; IS 3088900
• Manufacturer (Section G): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, israel 30889 00; IS 3088900
• Manufacturer Contact: tracey wielinski ; 5 casie lane; pepperell, MA 01463 ; 4409155833
• MDR Report Key: 7312279
• MDR Text Key: 101466837
• Report Number: 3010606081-2018-00001
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 1021-02
• Device Lot Number: 1508051
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 03/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2015
• 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; Required Intervention
• Patient Age: 71 YR