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

Model Number	51900
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Codes	Hypoglycemia (1912); Confusion/ Disorientation (2553)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspected device evaluated by ok biotech and calculated that the meter operated within specifications.We tested the standby current of returned meter, the result was 14.1a.The criteria is <55a.Pass.Meter setting, audio and all buttons function are ok.Because patient did not return his strips, so we tested the suspected meter with in house control solution and retain strips (same as patient's strip, lot number: d180124-1).The control solution tests for level low were 61/56 mg/dl; for level high were 247/247 mg/dl.The request control solution ranges are: level low 30~80 mg/dl; level high 210~320 mg/dl.All results were within the acceptance range.Pass.According to pdc's record, caller was using during the date of the medical attention have red desiccants, indicating that the ts may have been exposed to humidity or moisture.Patient used those strips to test blood might caused or contributed to incorrect readings.User storage or operation issue.
Event or Problem Description
End-user stated that medical attention was sought on (b)(6) 2019 around 7:30 pm at his home.End-user stated that he was awake but not responding to verbal commands and his speech was slurring.He was tested with his prodigy meter and got a result of 35 mg/dl which prompted his wife to call ems.No medications or food was consumed by the end-user while waiting for the ems to arrive.Paramedics arrived within approximately 5 minutes, and when tested with the ems meter his blood glucose was 50 mg/dl.The paramedics administered a glucose iv and transported him to the hospital.The enduser was stated that upon arriving at the hospital his blood glucose was around 35-45 mg/dl.The dr at the hospital gave the enduser another shot of a glucose solution and he ate a turkey sandwich apple juice and 2 containers of vanilla pudding.Prior to discharge the end-users blood glucose was 102 mg/dl.He was not admitted and was discharged after about 3 hours from (b)(6) healthcare located at (b)(6).The test strips the caller was using during the date of the medical attention have red desiccants, indicating that the ts may have been exposed to humidity or moisture.

• 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: 8987595
• Report Number: 3005862821-2019-00043
• Device Sequence Number: 16896103
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 01/24/2020
• Device Model Number: 51900
• Device Catalogue Number: 51900
• Device Lot Number: D180124-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• 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: 50 YR
• Patient Weight: 136