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

Model Number	51850
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Numbness (2415)
Date of Event	08/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Because device was not returned to ok biotech, therefore, we were unable to perform further testing on the suspected device.Ok biotech reviewed the manufacturing record of this suspected device (meter serial number # (b)(4)), and the meter was qualified and released by the quality control department and shipped to pdc on 02/15/2017.The strip lot # d190201-2 was manufactured on feb.01, 2019 and expired in feb.01, 2021.Ok biotech received no complaints from same manufacturing batch of strips.We tested the retain strips of same batch with our in house meter and control solution.The control solution tests for level low were 60/59 mg/dl; for level high were 240/232 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 200~310 mg/dl.All results were within the acceptance range.Pass.We are unable to confirm the complaint because device was not returned and no further information from customer has been received, this matter has to be closed out with undetermined root cause.
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 around 5:00 pm at her home.End-user stated that her prodigy meter gave her a result of 291 mg/dl and about 10 minutes after that she started to feel dizzy and her fingers got numb so she called the paramedics.Paramedics arrived within 15 minutes and tested with their meter and got a result of 115 mg/dl.Paramedics did not provide any treatment for her blood glucose level; however, they did transport her to the hospital due to her blood pressure being high.End-user does not recall what her blood glucose was upon arriving at the hospital.End-user stated the hospital tested her urine and blood pressure.She was told she has a bladder infection and her blood pressure is high, but she does not recall what the numbers were.She was instructed to follow up with her primary dr.Enduser stated that she was not admitted she was discharged after about 3 hours.The end-user was treated at (b)(6) medical center located at (b)(6).No additional information was provided.

• Brand Name: PRODIGY AUTOCODE
• Common Device Name: BLOOD GLUCOSE MONITORING DEVICE
• Manufacturer (Section D): OK BIOTECH CO., LTD.; no. 91, sec. 2; gongdao 5th road; hsinchu city, 30070 ; TW 30070
• MDR Report Key: 8987596
• Report Number: 3005862821-2019-00044
• Device Sequence Number: 3169207
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K073118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/01/2021
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D190201-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/11/2019
• 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
• Patient Age: 81 YR
• Patient Weight: 68