MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD PRODIGY AUTOCODE METER; BLOOD GLUCOSE MONITORING DEVICE,

Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Shaking/Tremors (2515); Confusion/ Disorientation (2553)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2019 around 11:00am.End-user stated that he took a blood glucose test and received a result of 293mg/dl, a normal result for that time of day is 125mg/dl.He then stated that he started to feel shaky and confused.End-user stated he went to the hospital on his own.There was no food drink or medication taken prior to going to the hospital.He does not recall what is blood glucose was when he arrived.He did not receive treatment for his blood glucose levels.Doctors in the emergency room ran a cat scan and blood work and everything came back normal.End-user stated he was at the hospital for 5 hours and was not admitted.The end-users sliding scale is as follows: humalog: (sliding scale): 100-199mg/dl 7 1/2 units 200-299mg/dl 15 units 300-399mg/dl 22 1/2 units 400-499mg/dl 30 units.End-user does not recall what his blood glucose was when he was discharged from (b)(6) hospital located at (b)(6).No additional details were provided.

• Brand Name: PRODIGY AUTOCODE METER
• 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: 8780859
• Report Number: 3008789114-2019-00025
• Device Sequence Number: 2014356
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/11/2019
• Report Date (Section F): 07/11/2019

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: 07/03/2019
• Event Location: Home
• Date Report to Manufacturer: 07/11/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2019
• 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: AMITRIPTYLINE; ATORVASTATIN; BUSPIRONE; HUMALOG; LOSARTAN; MORPHINE; OXYCODONE; TAMSULOSIN; TRESIBA; VENLAFAXINE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 92
• Date Report Sent to FDA: 07/11/2019