MAUDE Adverse Event Report: EPS BIO TECHNOLOGY CORP. EASYMAX NG SELF-MONITORING BLOOD GLUCOSE SYSTEM; GLUCOSE MONITORING SYSTEM

Model Number 100702332

Device Problems No Display/Image (1183); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2020

Event Type  malfunction  

Event Description

Can't turn on / no image.

• Brand Name: EASYMAX NG SELF-MONITORING BLOOD GLUCOSE SYSTEM
• Type of Device: GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): EPS BIO TECHNOLOGY CORP.; no.8 r&d rd.iii; hsinchu science park; hsinchu, 30076 ; TW 30076
• Manufacturer (Section G): EPS BIO TECHNOLOGY CORP.; no.8 r&d rd.iii; hsinchu science park; hsinchu, 30076 ; TW 30076
• Manufacturer Contact: iden chen ; no.8 r&d rd.iii; hsinchu science park; hsinchu, 30076 ; TW 30076
• MDR Report Key: 10099714
• MDR Text Key: 193432648
• Report Number: 3004130086-2020-00009
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K121207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/29/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 100702332
• Device Catalogue Number: 100702332
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1