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); Seizures (2063)
Date of Event	08/01/2019
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 07/07/2017.The strip lot # d181114-2 was manufactured on 11/14/2018 and expired in 11/14/2020.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 242/236 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 210~320 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 at his home.End-user stated that he was seizing in his sleep at around 5 am.He stated his wife found him and called paramedics.End-user had tested with his prodigy meter the night before at bed time (about 9 hours prior) and received a result of 326mg/dl he said he then adjusted his insulin pump.While waiting for the paramedics to arrive his wife gave him apple juice.When the paramedics arrived about 20-30 minutes later they tested his blood glucose and received a result of 30mg/dl on their meter.Paramedics did not test with the prodigy meter.He was not treated by the paramedics for his low blood sugar.He was not transported to the hospital.When paramedics left his blood glucose was 70mg/dl.End-user stated that there have been no changes to his medication but that he did turn his insulin pump down to prevent the event from reoccurring.No additional details were 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: 8968351
• Report Number: 3005862821-2019-00039
• Device Sequence Number: 16774568
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/08/2019

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: 11/14/2020
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D181114-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/06/2019
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 70