MAUDE Adverse Event Report: TYSON BIORESEARCH, INC. EUSY TOUCH BLOOD GLUCOSE MONITORING SYSTEM

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

Meter is not working.There was no report of death, serious injury or mistreatment associated with this event.

• Brand Name: EUSY TOUCH BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): TYSON BIORESEARCH, INC.; 5f., no. 16, 18, 20, 22,; kedong 3rd rd., zhunan,; miaoli county, taiwan 35053 ; TW 35053
• Manufacturer (Section G): TYSON BIORESEARCH, INC.; 5f., no. 16, 18, 20, 22,; kedong 3rd rd., zhunan,; miaoli county, taiwan 35053 ; TW 35053
• Manufacturer Contact: vance chang ; 5f., no. 16, 18, 20, 22,; kedong 3rd rd., zhunan,; miaoli county, taiwan 35053 ; TW 35053
• MDR Report Key: 8093759
• MDR Text Key: 128040383
• Report Number: 3003132490-2018-00010
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K101543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2018
• Event Location: Home
• Date Report to Manufacturer: 11/07/2018
• Date Manufacturer Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1