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

Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hypoglycemia (1912); Blurred Vision (2137); Sweating (2444)
Date of Event	06/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2019 around 4:30pm.The end-user stated that he took a blood glucose test with his prodigy meter and received a 81mg/dl.He stated that he felt as though his blood glucose was low, so he called paramedics.A normal reading for the end-user at that time of day is around 176-200mg/dl.The end-user called the paramedics about 20 minutes after testing.The paramedics arrived within 5 minutes and tested his blood glucose and received a result of 41mg/dl.The end-user stated that he took 2 sugar pills while waiting for the paramedics to arrive.The end-user was not transported to the hospital.He had 2 (b)(6) and a pizza while paramedics were there.End-user was not aware of what his blood glucose was before the paramedics left his home.He was unable to provide his medication list and attempts were made to retrieve this information but were unsuccessful.No additional details were provided.

• Brand Name: PRODIGY VOICE 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: 8754089
• Report Number: 3008789114-2019-00022
• Device Sequence Number: 16743690
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/02/2019
• Report Date (Section F): 07/02/2019

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: 06/12/2019
• Event Location: Home
• Date Report to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2019
• 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: LANTUS 55 UNITS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 83
• Date Report Sent to FDA: 07/02/2019