MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD PRODIGY AUTO CODE; BLOOD GLUCOSE MONITORING DEVICE

Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller stated that medical attention was sought on (b)(6) 2019 around 4:00pm at the end-user's home.Caller stated that her husband was not responding to her verbally, was clenching his fist and breathing shallowly.Caller stated that she tested him with his prodigy meter an received a result of 21mg/dl.Caller then called the paramedics.No food or medication was consumed while waiting for medical attention, but he did eat (b)(6) and take 60 units of tuojeo prior to needing medical attention.Paramedics arrived around 15 minutes later and tested the end-user with their meter and received a result of 50mg/dl.The paramedics administered glucose in an iv and transported the end-user to the hospital.Caller is unable to recall what the end-users blood glucose was when they arrived at the hospital.The end-user did not receive any treatment for his blood glucose while at the hospital other than the glucose iv.The end-user had his medication changed from lantus to toujeo 3 days prior to seeking medical attention.The end-user was told to follow up with his primary dr.He was treated at (b)(6) health system located at (b)(6).

• Brand Name: PRODIGY AUTO CODE
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 8888999
• Report Number: 3008789114-2019-00036
• Device Sequence Number: 14109636
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section F): 08/13/2019

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/09/2019
• Event Location: Home
• Date Report to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALPRAZOLAM; AMITRIPTYLINE; AMLODIPINE BESYLATE; BUPROPION; CLOPIDOGREL; HYDRALAZINE; MELATONIN; METFORMIN; METOPROLOL SUCCINATE; OMEPRAZOLE; SERTRALINE; TERAZOSIN; VITAMIN D2
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 63 YR
• Patient Weight: 91
• Date Report Sent to FDA: 08/13/2019