MAUDE Adverse Event Report: OK BIOTECH CO., LTD. PRODIGY AUTOCODE; BLOOD GLUCOSE MONITORING DEVICE

Model Number 51850

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 (b)(6) medical center located at (b)(6).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.

Manufacturer Narrative

1.No nonconformance was found in the document (qa-w-21-03) after okb reviewed device history record (dhf) of the complained products (meter serial#: (b)(4) and strips lot#: d180920-1).2.The suspected meter was shipped to pdc on 2017-07-07 and strips lot#d180920-1 was manufactured on 2018-09-20 and expiried 2 years before (expired in sep.2020).Because patient did not send back the suspected meter to us and patient used the expired strips to test her blood which may produced inaccurate blood glucose readings.3.The warning information regarding not to use expired strips was disclosed in user's manual and strip labeling to avoid this problem.Furthermore, the expiration date was shown clearly on the strip label, strip box and kit box.Therefore, the root cause of the complaint resulted from user's improper operation.

• Brand Name: PRODIGY AUTOCODE
• Type of Device: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• Manufacturer (Section G): OK BIOTECH CO., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• Manufacturer Contact: joanna wang ; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 16057857
• MDR Text Key: 306235921
• Report Number: 3005862821-2022-00015
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/20/2020
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D180920-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LASIX; LISINOPRIL; METFORMIN; METOPROLO
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 110 KG