MAUDE Adverse Event Report: SHENZHEN YUWEN E-COMMERCE CO., LTD. AUVON BLOOD GLUCOSE MONITORING SYSTEM; SINGLE USE ONLY BLOOD LANCET WITH AN INTEGR

Model Number	DS-W
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
1.Describe event received mdr report from fda (no.: mw5163034).Regarding the customer's continuous glucose monitoring (cgm) and blood glucose monitoring (bgm) tests, the bgm test results were higher.2.Root causes the user used bcg to calibrate its cgm.Bgm and cgm are using different approaches which will get different results.The bgm measures blood glucose levels in blood and the cgm monitors the glucose levels in interstitial fluid, they are analyzing two different types of fluids and using two types of methods, so the blood sugar value measured with different types of monitoring system will be different.3.Survey results and explanations our product complies with iso15197 regulations for the accuracy and compare with international standard of biochemistry, ysi 2300.The acceptance criteria of the accuracy should fall within ±15 mg/ dl for glucose concentrations <100 mg/dl and ±15% for concentrations[?]100 mg/dl.).Furthermore, we will also compare with state of the art meter, roche meters, as reference.Basically, each blood glucose manufacturer will set an acceptance limit that suits its own blood glucose meter.If the freestyle setting is close to low acceptance criteria of -10~-15%, and we set close to high acceptance criteria of +10-15%, then the values of these two will be a difference of about 20~30%, but both comply with the iso 15197:2013 standard of ±15%.For cgm, the sensor readings that are within ± 20% of the bg meter value for bg meter values[?] 70 mg/dl and within ± 20 mg/dl of the bg meter value for bg meter values <70 mg/dl.So the benchmarks are different.Theoretically, the bgms measure blood glucose levels in blood and the cgms monitor the glucose levels in interstitial fluid; they are analyzing two different types of fluids and using two types of methods.Different body fluids can sometimes give different numbers, so there will be times when the readings on user's fingertip and on user's cgm temporarily don't match.Usually these two methods have 10-20% of differences(here's another comment for your reference: https://popsdiabetes.Com/cgm-vs-bgm/).Specific related documents can be found in attachment 4and attachment 5.
Event or Problem Description
The customer bought an auvon glucose monitoring system because her practitioner was concerned she might be behaving hypoglycemic events.She did a series of 3 dexcom cgm's and one cgm had erratic results so she bought the auvon kit online to verify and recalibrate the cgm.But, her values on the auvon were consistently 20-40mg/dl over the numbers shown on the cgm.She would prick multiple fingers using new sticks and lancets and would get a wide range of numbers (over 40dl/ml) over 2 minutes.On advice of other diabetic brother, she purchased a freestyle blood glucose machine and it correlated statistically to the cgm every time.Her numbers are usually 85-115, and the auvon unit often had her numbers between 122 and 140 over many sticks and situations.She just started her last cgm yesterday.Today the cgm said 102, freestyle 96, and auvon says 138.She hope us investigate things like this.

• Brand Name: AUVON BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: SINGLE USE ONLY BLOOD LANCET WITH AN INTEGR
• Manufacturer (Section D): SHENZHEN YUWEN E-COMMERCE CO., LTD.; room 703, zhonghuicai building; longhua street; shenzhen, guangdong 51810 9; CH 518109
• Manufacturer (Section G): ALLIANCE INTERNATIONAL MEDICAL CO., LTD.; no.54, ying tao rd.; yinge town,taipei county; taipei, yinge town ; TW
• Manufacturer Contact: brenda hsu ; no.54, ying tao rd., yinge town,taipei county; taiwan; taipei, yinge town ; TW
• MDR Report Key: 21064168
• Report Number: 3013957847-2024-00001
• Device Sequence Number: 14307197
• Product Code: NBW
• UDI-Device Identifier: 06971292001324
• UDI-Public: (01)06971292001324(11)2024-08-01(10)AUYLS02920240606001
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K132663
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2026
• Device Model Number: DS-W
• Device Lot Number: AUYLS02920240606001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White