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); Confusion/ Disorientation (2553)
Date of Event	08/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 around 8pm at the end-user's home.End-user stated she fell asleep on a chair and her daughter attempted to wake her around 8:00pm.The end-user was feeling confused and was not verbally responding to her daughter.End-user stated that her daughter gave her 2 glucose tablets via mouth and tested her blood glucose on her prodigy meter and received a result of 95mg/dl.Her daughter called paramedics about 10minutes after testing with her prodigy meter.Paramedics arrived approximately 15 minutes later and tested the end-users blood glucose and received a result of 52mg/dl.The paramedics administered glucose though an iv and transported her to (b)(6).Upon arriving at the hospital, the end-user had a blood glucose of 138mg/dl.The doctors gave the caller some apple juice and chicken on a roll.The end-user was not admitted to the hospital and was discharged after 4 hours with a blood glucose of 140mg/dl.

• 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: 8883771
• Report Number: 3008789114-2019-00033
• Device Sequence Number: 2549017
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 08/12/2019
• Report Date (Section F): 08/12/2019

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: 08/07/2019
• Event Location: Home
• Date Report to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2019
• 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: ASPIRIN; LEVEMIR; LEVOTHYROXINE; LOSARTAN; LOSARTAN; METOPROLOL; NOVALOG; VITAMIN D; ZOCOR; ZOSYN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 78 YR
• Patient Weight: 86
• Date Report Sent to FDA: 08/12/2019