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

Model Number	100603503
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported product was not returned for testing.Several lots of test strips and meters which were possibly involved in the incident were sorted out and tested.The selected lots performed within specification.Customer did not return product and did not have control solution to ensure the quality of the product.(b)(4).
Event or Problem Description
We received a voluntary event report from fda with report number: mw5079747.We contacted the patient and she said she got high readings of 443/507/499 mg/dl from the easymax v glucose meter.Because the patient is on a sliding scale and didn't want to give herself that much insulin, she called the ems and received only 204 mg/dl.She brought this device about a year ago and never dropped the device.She did not leave the test strip vial unclosed and stores in the kitchen cabinet.She did not have and use the control solution to check the device and test strip.Replace product to her.

• Brand Name: EASYMAX V SELF-MONITORING BLOOD GLUCOSE SYSTEM
• Common Device Name: GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): EPS BIO TECHNOLOGY CORP.; no. 8 r&d rd.iii; hsinchu science park; hsinchu, 30077 ; TW 30077
• MDR Report Key: 8036521
• Report Number: 3004130086-2018-00001
• Device Sequence Number: 1463695
• Product Code: NBW
• UDI-Device Identifier: 00885017000058
• UDI-Public: 00885017000058
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K092894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 100603503
• Device Catalogue Number: 100603503
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5079747
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 105