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

Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Seizures (2063); Loss of consciousness (2418); Sweating (2444)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller stated that medical attention was sought on (b)(6) 2019 at his home.Caller reported that the meter is reading higher than normal.Caller stated the meter read 96 mg/dl and he passed out and started to have a seizure with cold sweats 2 minutes later and she proceeded to call 911.Paramedics arrived within 5 minutes and their meter read 32 mg/dl.No medication was given while waiting for paramedics due to the end-user being seizing and being unresponsive.Paramedics gave the end-user a glucose solution by iv.End-user was not transported to the hospital.Paramedics advised him to eat something when they left.Caller is unsure of what his blood glucose was when the paramedics left.

• 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: 8878415
• Report Number: 3008789114-2019-00031
• Device Sequence Number: 2048047
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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 B): 08/08/2019
• Report Date (Section F): 08/08/2019

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: 08/02/2019
• Event Location: Home
• Date Report to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2019
• 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: AMLODIPINE 10 MG; ASPIRIN; ATORVASTATIN 10 MG; CLOPIDOGREL 75 MG; LISINOPRIL 5MG; TRESIBA 22 UNITS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 68
• Date Report Sent to FDA: 08/08/2019