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

Model Number	51900
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hypoglycemia (1912); Blurred Vision (2137); Sweating (2444)
Date of Event	06/12/2019
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 12.3¿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 returned strips (strip lot number: d180713-1).The control solution tests for level low were 61/62 mg/dl, for level high were 269/270 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 230~340 mg/dl.All results were within the acceptance range.Pass.We tested the retain strips from our warehouse (same as patient's strip, lot number: d180713-1).The control solution tests for level low were 60/60 mg/dl; for level high were 269/267 mg/dl.The request control solution ranges are: level low 35~85 mg/dl; level high 230~340 mg/dl.All results were within the acceptance range.Pass.
Event or Problem Description
It was reported that medical attention was sought on (b)(6) 2019 around 4:30pm.The end-user stated that he took a blood glucose test with his prodigy meter and received a 81mg/dl.Hew stated that he felt as though his blood glucose was low, so he called paramedics.A normal reading for the end-user at that time of day is around 176- 200mg/dl.The end-user called the paramedics about 20 minutes after testing.The paramedics arrived within 5 minutes and tested his blood glucose and received a result of 41mg/dl.The end-user stated that he took 2 sugar pills while waiting for the paramedics to arrive.The end-user was not transported to the hospital.He had 2 cokes and a pizza while paramedics were there.End-user was not aware of what his blood glucose was before the paramedics left his home.He was unable to provide his medication list and attempts were made to retrieve this information but were unsuccessful.No additional details were provided.

• Brand Name: PRODIGY VOICE
• 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: 8774946
• Report Number: 3005862821-2019-00031
• Device Sequence Number: 2666764
• Product Code: NBW
• UDI-Device Identifier: 00384840519008
• UDI-Public: 00384840519008
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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: 07/13/2020
• Device Model Number: 51900
• Device Catalogue Number: 51900
• Device Lot Number: D180713-1
• 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: 07/02/2019
• 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: LANTUS 55 UNITS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 83