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

Model Number 51850

Device Problem High Test Results (2457)

Patient Problems Chest Pain (1776); Hyperglycemia (1905); Pneumonia (2011)

Event Date 02/08/2018

Event Type  Injury  

Event Description

It was reported that medical attention was sought on (b)(6) 2018 at 5:00 pm after the end user alleged she received higher than normal blood glucose results from her prodigy diabetes meter.The end user was experiencing symptoms associated with pneumonia - coughing, wheezing, heavy breathing and chest pains.The paramedics were called and while waiting on their arrival a blood glucose test was performed with her prodigy diabetes meter and the result was 487 mg/dl.Subsequently upon their arrival the paramedics performed a blood glucose test with their meter and the result was 130 mg/dl.No treatment was administered and the end user was transported to the er.Once she arrived to the er an additional blood glucose test was performed with the hospitals meter and the result was 130 mg/dl and no further treatment was warranted.A chest x-ray was performed with close observation.After 5 hours in the er the end user was discharged and stated she has an upcoming appointment with her pcp and a cardiologist.No additional details were provided in regards to this medical event.

• Brand Name: PRODIGY AUTO CODE
• Type of Device: BLOOD GLUCOSE MONTIORING DEVICE
• Manufacturer (Section D): OK BIOTECH COMPANY LTD; no. 91, sec 2; gongdao 5th rd; hsinchu, 300 ; TW 300
• MDR Report Key: 7276758
• MDR Text Key: 100279670
• Report Number: 3008789114-2018-00016
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00384841518505
• UDI-Public: 00384841518505
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2018,02/13/2018

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
• Device Operator: Lay User/Patient
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2018
• Distributor Facility Aware Date: 02/13/2018
• Event Location: Home
• Date Report to Manufacturer: 02/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ABUDURAL; ALBUTEROL; BD INSULIN PEN NEEDLE - UF LANTUS; BENEFIBER; CALACLEAR LOTION; CHOLECALCIFEROL; CLOPIDOGREL; CLOTRIMAZOLE CREAM; CRANBERRY EXTRACT; DILTIAZEM; DOCUSATE SODIUM; ESCITALOPRAM OXALATE; EZETIMIBE; FLONASE; FUROSEMIDE; GABAPENTIN; HYDROCODONE; INSULIN ASPART- NOVOLOG; LAMOTRIGINE; LANTUS SOLOSTAR; LORAZEPAM; METOPROLOL SUCCINATE; MULTIVITAMIN; NITROSTAT; PANTOPRAZOLE; POTASSIUM CHLORIDE; PRO AIRFASA; RANEXA; SILVADENE; TRAMADOL; VICKS VAPORUB OINTMENT; VITIMIN C; WARFARIN
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 120