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	Hypoglycemia (1912); Dizziness (2194); Numbness (2415)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 around 5:00pm at her home.End-user stated that her prodigy meter gave her a result of 291 mg/dl and about 10 minutes after that she started to feel dizzy and her fingers got numb so she called the paramedics.Paramedics arrived within 15 minutes and tested with their meter and got a result of 115 mg/dl.Paramedics did not provide any treatment for her blood glucose level; however, they did transport her to the hospital due to her blood pressure being high.End-user does not recall what her blood glucose was upon arriving at the hospital.End-user stated the hospital tested her urine and blood pressure.She was told she has a bladder infection and her blood pressure is high, but she does not recall what the numbers were.She was instructed to follow up with her primary dr.End-user stated that she was not admitted she was discharged after about 3 hours.The end-user was treated at (b)(6) regional medical center located at (b)(6).No additional information was provided.

• 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: 8888746
• Report Number: 3008789114-2019-00035
• Device Sequence Number: 16199945
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/13/2019
• 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: AMLODIPINE; ASPIRIN; BUSPIRONE; CARVEDILOL; FUROSEMIDE; GABAPENTIN; GLIPIZIDE; LOVASTATIN; OMEPRAZOLE; TRIAMTERENE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 81 YR
• Patient Weight: 68
• Date Report Sent to FDA: 08/13/2019