MAUDE Adverse Event Report: OK BIOTECH COMPANY LTD PRODIGY AUTO CODE; BLOOD GLUCOSE MONITORING DEVICE

Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Fainting (1847); Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	07/20/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporter stated that medical attention was sought on (b)(6) 2019 around 12pm.End-user was eating and stated they needed to go to the bathroom.End-user took glipizide prior to dinner, they fell over in their chair and was too weak to move.Reporter helped end-user to the bathroom and performed a bgt, meter read 379mg/dl.Caller picked up the end-user and brought them to their bed and called the paramedics.Paramedics arrived about 25minutes later, end-user was responsive but was confused.Paramedics performed a bgt on their meter and it read 25mg/dl and then performed a bgt on the prodigy and received a result of 178mg/dl.Paramedics gave the end-user glucose through an iv.The paramedics transported the end-user to the er where upon arrival her blood glucose was 32mg/dl when tested with the hospitals meter.She was then admitted for 2 days.Caller does not remember what other bgt were performed or the discharge result.The doctor took the end-user off the glipizide after medical attention was sought.A cat scan was performed, and the results were normal.She was treated at (b)(6) medical center emergency room located at (b)(6).

• 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: 8848462
• Report Number: 3008789114-2019-00028
• Device Sequence Number: 14088596
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/31/2019
• Report Date (Section F): 07/31/2019

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: 07/22/2019
• Event Location: Home
• Date Report to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Weight: 48
• Date Report Sent to FDA: 07/31/2019