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

Model Number	51900
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
End-user alleged that on (b)(6) 2018 around 0730 the paramedics were called due to symptoms of hypoglycemia.End-user alleged the meter would not provide a result and would display the low battery error code, e-b.It is unknown when the end-user last received a numerical result on the prodigy meter.Paramedics arrived and performed a blood glucose test on the end-user and received a 20 mg/dl with their meter.End-user was treated with iv fluids (unknown concentration of fluids) to raise his blood glucose.End-user was transported to the hospital, upon arrival end-user alleged his blood glucose was 20mg/dl and he received more iv fluids to raise his blood glucose level.End-user remained in the hospital for 5 days and no other treatment was provided.Upon discharge the end-user's blood glucose was reported to be 180 mg/dl.End-user was advised to follow up with pcp and to start a sliding scale with basaglar.End-user stated he did not know the prescribed sliding scale.No additional details were provided in regards to tis medical event.

• Brand Name: PRODIGY VOICE
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu 300, tw ; TW
• MDR Report Key: 7462747
• Report Number: 3008789114-2018-00025
• Device Sequence Number: 1592545
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/25/2018
• Report Date (Section F): 04/25/2018

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: 51900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2018
• Event Location: Home
• Date Report to Manufacturer: 04/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2018
• 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; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 84
• Date Report Sent to FDA: 04/25/2018