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

Model Number	50302
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2017 at 10:30 am after the end users prodigy diabetes meter was not operating properly and he was unable to obtain an appropriate reading.The end user experienced a low blood glucose seizure accompanied with a reading of 62 mg/dl.The paramedics were called and upon arrival they performed a blood glucose test with their meter and the result was 42 mg/dl.The end user was given an iv and dextrose injection along with being transported to the er.Simultaneously he received another dextrose injection and iv saline.A blood glucose test was performed as well as examining his potassium levels.At the time of this call the end user was currently still in the hospital and no additional details were provided in regards to this medical event.

• 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, 300 ; TW 300
• MDR Report Key: 6858814
• Report Number: 3008789114-2017-00087
• Device Sequence Number: 637067
• Product Code: NBW
• UDI-Device Identifier: 00384840503021
• UDI-Public: 00384840503021
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/08/2017
• Report Date (Section F): 09/12/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 50302
• Device Catalogue Number: 50302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/08/2017
• Event Location: Home
• Date Report to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2017
• 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: APIDRA - SLIDING SCALE; LEVEMIR- 80 UNITS IN THE MORNINGS
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 22 YR
• Patient Weight: 82
• Date Report Sent to FDA: 09/12/2017