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

Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Caller stated that medical attention was sought on (b)(6) 2019 around 8pm at the end-user's home.Caller stated that the end-user took a blood glucose test and received a result 50mg/dl.A normal result for the end-user for that time of day is 150-200mg/dl.Prior to seeking medical attention, the end-user had dinner and took his prescribed medications.Caller stated that the end-user appeared awake but was not responsive, so she called ems.Caller stated that while waiting for the ens to arrive she tried to give the end-user candy, but he was not responding.Ems arrived 10-15 minutes after testing with the prodigy meter.They tested the end-user with there meter and received a result of 30mg/dl.The end-user was still unresponsive, and the ems administered a glucose iv.End-user was the transported to (b)(6).Caller was unsure of what his blood glucose was upon arriving at the hospital.Caller was unable to provide what treatment the end-user received due to not be allowed in the back ant the er.She stated that he was not admitted and was there approximately 8 hours.Caller was unable to recall what the end-users blood glucose was when he was discharged or what instructions he may have received.The end -user is on a sliding scale that is as follows tresiba: 20 units in the morning.Novolog: sliding scale, 150-200mg/dl=1 unit, 201-250mg/dl=2 units, 251-300mg/dl=3 units, 301-350mg/dl=4 units, 351-400mg/dl=5 units, 401-450mg/dl=6 units, and call emt if result is below 70 mg/dl or over 450 mg/dl.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: 8883451
• Report Number: 3008789114-2019-00032
• Device Sequence Number: 2548457
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 08/06/2019
• 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: ATORVASTATIN; BUPROPION; FLUDROCORTISONE; FLUOXETINE; FOLIC ACID; GABAPENTIN; MIDODRINE; POTASSIUM CL ER; RESTASIS EYE DROPS
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Weight: 64
• Date Report Sent to FDA: 08/12/2019