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 Code	Sweating (2444)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 at her home.End-user stated that she received a result of lo when testing her blood sugar.End-user then stated that she tried testing with her prodigy meter 10 times and continued to get a reading of lo.She then tried to raise her blood sugar by eating cake cookie and juice.She then said she started sweating and had feelings of nervousness.End-user stated she took metformin 1000mg/dl.She proceeded to drive herself to the emergency department where upon arrival her blood glucose was 188mg/dl.She was not treated for her blood glucose due to her level being ok when she arrived at the hospital.She stated that she was prescribed amoxicillin 500mg/dl but did not disclose why she was given the antibiotic.End-user was told to follow up with her primary care dr.She was treated at (b)(6) hospital located at (b)(6) for 5 hours and was not admitted.

• 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: 8870683
• Report Number: 3008789114-2019-00029
• Device Sequence Number: 3294311
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/07/2019
• Report Date (Section F): 08/07/2019

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: 07/29/2019
• Event Location: Home
• Date Report to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2019
• 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: CYMBALTA; IRON; METFORMIN; SIMVASTATIN; VITAMIN D3
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 61 YR
• Patient Weight: 88
• Date Report Sent to FDA: 08/07/2019