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	Seizures (2063); Loss of consciousness (2418); Sweating (2444)
Date of Event	08/02/2019
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 (b)(6) 2017.The strip lot # d181026-1 was manufactured on 10/26/2018 and expired in 10/26/2020.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 58/55 mg/dl; for level high were 230/239 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
Caller stated that medical attention was sought on (b)(6) 2019 at his home.Caller reported that the meter is reading higher than normal.Caller stated the meter read 96 mg/dl and he passed out and started to have a seizure with cold sweats 2 minutes later and she proceeded to call 911.Paramedics arrived within 5 minutes and their meter read 32 mg/dl.No medication was given while waiting for paramedics due to the end-user being seizing and being unresponsive.Paramedics gave the end-user a glucose solution by iv.End-user was not transported to the hospital.Paramedics advised him to eat something when they left.Caller is unsure of what his blood glucose was when the paramedics left.
Event or Problem Description
This is a supplemental report to initial report 3005862821-2019-00040 to submit investigation results from the manufacturer for the suspect devices.Devices were returned from prodigy diabetes care on (b)(6) 2019 and an investigation results of the suspect devices were completed by ok biotech.
Additional Manufacturer Narrative
Suspected device evaluated by ok biotech and calculated that the meter operated within specifications.1.We tested the standby current of returned meter, the result was18.1 a.The criteria is <55 a.Pass.2.Meter setting, audio and all buttons function are ok.4.Patient send back empty strip bottle but no strips inside.The desiccant color had changed in the bottle.3.We tested the suspected meter with in house control solution and retain strips (same as patient's strip, lot number:d181026-1 ).The control solution tests for level low were 57/57 mg/dl; for level high were 237/234 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.Because the desiccant color changed from patient's strips bottle, indicate the strips might get moisture.Patient used those strips to test blood might caused or contributed to incorrect readings.User storage or operation issue.

• 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: 8968350
• Report Number: 3005862821-2019-00040
• Device Sequence Number: 2559940
• 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,Followup
• 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: 10/26/2020
• Device Model Number: 51850
• Device Catalogue Number: 51850
• Device Lot Number: D181026-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: AMLODIPINE 10 MG; ASPIRIN; ATORVASTATIN 10 MG; CLOPIDOGREL 75 MG; LISINOPRIL 5MG; TRESIBA 22 UNITS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 68