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	Fatigue (1849); Shaking/Tremors (2515)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Suspected device evaluated by ok biotech and calculated that the meter operated within specifications.Ok biotech tested the standby current of returned meter, the result was 0.9¿a.The criteria is <55¿a.Pass.Meter setting, audio and all buttons function are ok.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 61/62 mg/dl, for level high were 261/256 mg/dl.The request control solution ranges are: level low 30~80 mg/dl; level high 190~290 mg/dl.All results were within the acceptance range.Pass.Patient's strips lot# d161007-2 was manufactured on oct.07, 2016 and expired in oct.2018.Patient used expired strips to test blood which might caused or contributed to error readings.User issue.
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2019 at the end-uses home.The end-user stated that she performed a blood glucose test around 10:00am and received a result that was 519mg/dl.A normal blood glucose reading for her is around 120mg/dl.End -user stated she wasn't feeling well, and she drove herself to (b)(6) health located at (b)(6).End-user stated that she does not remember what her blood glucose was when she arrived at the hospital just that it was higher than normal.She stated that she was given a tablet to lower her blood glucose.She was discharged after 6 hours and her blood glucose was around 200mg/dl.Meter memory was deleted so the end-user was unable to provide test results.End-user was informed that her test strips are expired.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: 8774945
• Report Number: 3005862821-2019-00028
• Device Sequence Number: 16638701
• Product Code: NBW
• UDI-Device Identifier: 00384840518858
• UDI-Public: 00384840518858
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/13/2019

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: 10/07/2018
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D161007-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BENAZEPRIL; BUMETANIDE; FELODIPINE; FENOFIBRATE; LYRICA; NOVOLOG 70/30; OMEPRAZOLE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Weight: 110