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	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	06/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2019 around 8:30pm.The caller stated that the end-user received a reading of 66mg/dl.End-user then took her insulin based off the result she received which led to the end-user being found unresponsive.Paramedics were called around 10 minutes after testing with her prodigy meter.Paramedics arrived within 10-15minutes and tested her blood glucose with their meter and received a result of 34mg/dl.There was about 20 minutes between testing with the prodigy meter and the paramedics meter.There was no food drink or medications taken while waiting for the paramedics.The end-user was given 2 glucose iv solutions and was not transported to the hospital.The end-user takes the following insulin lantus 25 units at noon, novolog 2-10 units when she eats, novolog 20 units when result is over 400mg/dl.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: 8780408
• Report Number: 3008789114-2019-00024
• Device Sequence Number: 1999647
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: 07/01/2019
• 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: AMLODIPINE; BESYLATE; FLUOXETINE; GABAPENTIN; HYDROCHLOROTHIAZIDE; LANTUS; NOVOLOG; RANITIDINE HCL; TRAZODONE; VITAMIN D; ZYRTEC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Weight: 64
• Date Report Sent to FDA: 07/11/2019