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	06/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 around 7:30pm at his home.End-user stated that he was awake but not responding to verbal commands and his speech was slurring.He was tested with his prodigy meter and got a result of 35 mg/dl which prompted his wife to call ems.No medications or food was consumed by the end-user while waiting for the ems to arrive.Paramedics arrived within approximately 5 minutes, and when tested with the ems meter his blood glucose was 50 mg/dl.The paramedics administered a glucose iv and transported him to the hospital.The end-user was stated that upon arriving at the hospital his blood glucose was around 35-45mg/dl.The dr at the hospital gave the end-user another shot of a glucose solution and he ate a turkey sandwich, apple juice, and 2 containers of vanilla pudding.Prior to discharge the end-users blood glucose was 102mg/dl.He was not admitted and was discharged after about 3 hours from (b)(6) healthcare located at (b)(6).The test strips the caller was using during the date of the medical attention have red desiccants, indicating that the ts may have been exposed to humidity or moisture.

• 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: 8887964
• Report Number: 3008789114-2019-00034
• Device Sequence Number: 11409789
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 08/13/2019
• Report Date (Section F): 08/13/2019

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: 08/13/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2019
• 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: ALPHA LIPOIC; ASPIRIN; BUSPIRONE; DIVALPROEX; DUPROTION; FENOFIBRIC; FUROSEMIDE; GABAPENTIN; GLIMEPIRIDE; HFA (INHALER); INGREZZA; LORATADINE; METOPROLOL; NOVOLOG 70/30 48 UNITS; NOVOLOG: 15; PERPHENAZINE; PRAMIPEXOLE; ROSUVASTATIN; SPIRIVA; TOPIRAMATE; TRIHEXYPHENIDYL; TRULICITY; VENTOLIN
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR
• Patient Weight: 136
• Date Report Sent to FDA: 08/13/2019