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); 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 at 2:30am at the end-user's home.The caller stated that the end-user woke up and felt ill.He then performed a blood glucose test and received a 76mg/dl.Reporter stated that she then called the paramedics due to him not feeling well.Paramedics were called 10 minutes after testing with his prodigy meter.Reporter stated that he had apple juice and sugar while waiting for the paramedics to come the paramedics arrived about 10 minutes later and tested his blood glucose and received a result of 60mg/dl, they then tested with the end-users prodigy meter and received a result of 86mg/dl.The end-user was not transported to the hospital.The paramedics had him eat a peanut butter sandwich.The end-user is on a sliding scale that is as follows: lantus: 14 units in the morning and 24 units at night.Novalog: 10 units (sliding scale: 150-200mg/dl add 2 units, 201-250mg/dl add 3 units, 251-300mg/dl add 4 units, 351-400mg/dl add 6 units).No additional information was 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: 8755339
• Report Number: 3008789114-2019-00023
• Device Sequence Number: 16625766
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 82
• Date Report Sent to FDA: 07/02/2019