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

Model Number 1021-04

Device Problem Low Readings (2460)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Event Description

On (b)(6) 2019, the customer posted on dariohealth (b)(6) page the following message: "the meter i bought is not accurate and caused me to go to the er really concerned and upset.The er doctor said throw it away and do not use.When i have contacted dario they have just given me lip service and have done nothing to help.So i am done with them.In my opinion they are selling an inferior product that can hurt people." following this post, dario service representatives tried to reach out to the customer in 3 different channels: a replied comment to the customer's post with dario contact details; a private message via (b)(6) , and phone calls (as per the customer's details in dario crm system).However, no response has been received to date.As per dario log, the customer did not use his dario meter since january 2019.Since the customer did not respond, there is not enough information to investigate and no resolution is available.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: NBW
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: olivier jarry ; 142 w. 57th street; 8th floor; new york,, NY 10019 ; 9147031073
• MDR Report Key: 8834617
• MDR Text Key: 179408497
• Report Number: 3010606081-2019-00019
• 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: 07/28/2019

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: No Information
• Device Model Number: 1021-04
• Device Lot Number: 1805021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR