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	07/09/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller stated that medical attention was sought on (b)(6) 2019 at 12:00pm.He stated he received a result of 420mg/dl, started to feel confused and went to an urgent care facility.A normal blood glucose result for him at that time of day is 140-150mg/dl.End-user stated that before going to the urgent care he took 8 units of humalog and ate 2 eggs, 1 piece of toast, and 2 sausage patties.Upon arriving at the urgent care, they called paramedics and he was transported to the emergency room.Upon arrival his blood glucose was 22mg/dl.End-user stated they checked his blood pressure did an ekg and both were normal.He said he received a glucose solution by mouth at the hospital.End-user stated he was at the hospital almost 3 hours but was not admitted.He is required to take 3 units of humalog if result is above 200.Prior to discharge the end-user stated his blood glucose was 75mg/dl.He was treated at (b)(6) hospital located at (b)(6).No additional details were 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: 8850049
• Report Number: 3008789114-2019-00027
• Device Sequence Number: 1400290
• 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): 07/12/2019
• Report Date (Section F): 07/25/2019

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?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2019
• Event Location: Home
• Date Report to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/01/2019
• 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; BICALUTAMIDE; CARVEDILOL; FUROSEMIDE; HUMALOG; LISINOPRIL; METFORMIN; POTASSIUM; SPIRONOLACTONE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Weight: 77
• Date Report Sent to FDA: 07/25/2019