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

Device Problem High Readings (2459)

Patient Problems Headache (1880); Dizziness (2194)

Event Date 11/18/2022

Event Type  Injury  

Event Description

Caller stated that she sought medical attention on (b)(6) 2022 around 10:30am at home.Caller stated that she tested her blood glucose with her prodigy meter and received a result of 400mg/dl.A normal result for this time of day is usually around 95-100mg/dl.Caller stated that she started feeling dizzy and had a slight headache about 5 minutes after testing with her prodigy meter.Caller stated that she then called paramedics.Caller stated that no food drink or medication were consumed while waiting for paramedics to arrive.Caller stated that the paramedics arrived within 5-10 minutes and tested her blood glucose with their meter and received a result of 130mg/dl.Caller stated she was then transported to centinela medical center located at 555 e hardy street inglewood, ca 90301.Caller stated that when she arrived at the hospital her blood glucose was 100mg/dl.Caller stated that an ekg was done with normal results.There was no treatment given to raise or lower her blood glucose.Caller stated that she was at the hospital for 9 hours and was given discharge instruction to see her primary doctor.Caller was using expired prodigy test strips.She was educated to never use expired products and to always discard them.No additional details were provided.

• Brand Name: PRODIGY AUTO CODE
• Type of Device: 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: 16034444
• MDR Text Key: 306009623
• Report Number: 3008789114-2022-00015
• Device Sequence Number: 1
• Product Code: NBW
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2022
• Distributor Facility Aware Date: 11/21/2022
• Event Location: Home
• Date Report to Manufacturer: 12/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASIX; LISINOPRIL; METFORMIN; METOPROLOL
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 110 KG