MAUDE Adverse Event Report: BROADMASTER BIOTECH CORPORATION. ADVOCATE; BLOOD GLUCOSE TEST STRIP

Model Number	BA006A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
User called in to say had meter about a year and meter gives her incorrect reading couple months ago compared to other meter.She compared with different brand is 135 mg/dl and the meter is 211 mg/dl.User said she didn't know the average glucose reading, because her glucose reading is up and down.
Additional Manufacturer Narrative
We asked user to run the control solution test to make sure the system working properly.User run the control solution twice and the results are both with in the coa range.Therefore user did the glucose glulcose reading test to compare with other brand meter, the meter got 92 mg/dl and other brand meter got 108 mg/dl.We didn't receive the suspected producsts and there is not enough information for investigation.

• Brand Name: ADVOCATE
• Common Device Name: BLOOD GLUCOSE TEST STRIP
• Manufacturer (Section D): BROADMASTER BIOTECH CORPORATION.; 2f., no.91, xiyuan rd.; zhongli dist.; taoyuan, taiwan 32057 ; TW 32057
• Manufacturer (Section G): BROADMASTER BIOTECH CORP.; 2f., no.91., xiyuan rd.,; zhongli dist.; taoyuan, taiwan 32057 ; TW 32057
• Manufacturer Contact: wilson yu ; 2f., no.91., xiyuan rd.,; zhongli dist.; taoyuan, taiwan 32057 ; TW 32057
• MDR Report Key: 17762202
• Report Number: 3009276320-2023-00002
• Device Sequence Number: 15268261
• Product Code: NBW
• UDI-Device Identifier: 00894046001578
• UDI-Public: 00894046001578
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K120183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2023

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
• Device Expiration Date: 12/15/2023
• Device Model Number: BA006A
• Device Lot Number: BA006A21L16A2D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 09/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Female
• Patient Weight: 71 KG