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	Hypoglycemia (1912); Seizures (2063)
Date of Event	08/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 at his home.End-user stated that he was seizing in his sleep at around 5 am.He stated his wife found him and called paramedics.End-user had tested with his prodigy meter the night before at bed time (about 9 hours prior) and received a result of 326mg/dl he said he then adjusted his insulin pump.While waiting for the paramedics to arrive his wife gave him apple juice.When the paramedics arrived about 20-30 minutes later they tested his blood glucose and received a result of 30mg/dl on their meter.Paramedics did not test with the prodigy meter.He was not treated by the paramedics for his low blood sugar.He was not transported to the hospital.When paramedics left his blood glucose was 70mg/dl.End-user stated that there have been no changes to his medication but that he did turn his insulin pump down to prevent the event from reoccurring.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: 8873908
• Report Number: 3008789114-2019-00030
• Device Sequence Number: 2742711
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/08/2019
• Report Date (Section F): 08/08/2019

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: 08/02/2019
• Event Location: Home
• Date Report to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2019
• 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: CETIRIZINE; LISINOPRIL; NOVOLOG; SIMVASTATIN; TRAZODONE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Weight: 70
• Date Report Sent to FDA: 08/08/2019