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); Confusion/ Disorientation (2553)
Date of Event	07/09/2019
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 18.3ua.The criteria is <55ua.Pass.Meter setting, audio and all buttons function are ok.Because patient did not send back his strips, so we tested the suspected meter with in house control solution and in house strips (strip lot number: d180315-1).The control solution tests for level low were 60/62 mg/dl, for level high were 245/249 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.
Event or Problem Description
Caller stated that medical attention was sought on 07/09/2019 at 12:00pm.He stated he received a result of 420 mg/dl, started to feel confused and went to an urgent care facility.A normal blood glucose result for him at that time of day is 140-150 mg/dl.End-user stated that before going to the urgent care he took 8 units of humalog and ate 2 eggs, 1 piece of toast, and 2 sausage patties.Upon arriving at the urgent care, they called paramedics and he was transported to the emergency room.Upon arrival his blood glucose was 22 mg/dl.End-user stated they checked his blood pressure did an ekg and both were normal.He said he received a glucose solution by mouth at the hospital.End-user stated he was at the hospital almost 3 hours but was not admitted.He is required to take 3 units of humalog if result is above 200.Prior to discharge the end-user stated his blood glucose was 75 mg/dl.He was treated at (b)(6) health hospital located at (b)(6).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: 8886284
• Report Number: 3005862821-2019-00036
• Device Sequence Number: 19554062
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/12/2019

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 Model Number: 51850
• Device Catalogue Number: 51850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 08/12/2019
• 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: 76 YR
• Patient Weight: 77