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

Model Number	51850
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2017 at 6:00 pm after the end user received higher than normal blood glucose readings from his prodigy diabetes meter.The end user performed a blood glucose test with a result of 336 mg/dl.He did not experience any significant symptoms but out of concern he was taken to the er as a precaution.Upon arrival to the er his blood glucose was 241 mg/dl.The end user stated that no treatment was administered to stabilize his blood glucose level.Blood and urine test were performed and the results were normal.After 4 hours in the er the end user was discharged with a blood glucose reading of 276 mg/dl and he was instructed to follow-up with his pcp.No additional details were provided in regards to this medical event.

• 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, 300 ; TW 300
• MDR Report Key: 6853299
• Report Number: 3008789114-2017-00086
• Device Sequence Number: 18843328
• Product Code: NBW
• UDI-Device Identifier: 00384841753005
• UDI-Public: 00384841753005
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/07/2017
• Report Date (Section F): 09/08/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/07/2017
• Event Location: Home
• Date Report to Manufacturer: 09/08/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2017
• 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 - 10MG ONCE A DAY; CYCLOBENZAPRINE - 5MG ONCE A DAY; GABAPENTIN - 600MG 3 X A DAY; WARFARIN - 5MG ONCE A DAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 91
• Date Report Sent to FDA: 09/08/2017