MAUDE Adverse Event Report: BROADMASTER BIOTECH CORPORATION ADVOCATE; BLOOD GLUCOSE METER

Model Number	BMB-EA001S
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Meter is not working even after replacing the batteries.Customer said she had it in the living room then all of a sudden, when she was about to use it the other day, it just won't work.
Additional Manufacturer Narrative
An extended investigation has been conducted.The investigation did not identify any indication that the product did not meet specification.
Event or Problem Description
Meter is not working even after replacing the batteries.Customer said she had it in the living room then all of a sudden, when she was about to use it the other day, it just won't work.

• Brand Name: ADVOCATE
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): BROADMASTER BIOTECH CORPORATION; 2f., no.91, xiyuan rd.; zhongli dist.; taoyuan city, taiwan 32057 ; TW 32057
• Manufacturer (Section G): BROADMASTER BIOTECH CORP.; 2f., no.91, xiyuan rd.; zhongli dist.; taoyuan city,, taiwan 32057 ; TW 32057
• Manufacturer Contact: wilson yu ; 2f., no.91, xiyuan rd.,; zhongli dist.,; taoyuan city,, taiwan 32057 ; TW 32057
• MDR Report Key: 17601891
• Report Number: 3009276320-2023-00001
• Device Sequence Number: 12296875
• Product Code: NBW
• UDI-Device Identifier: 00894046001882
• UDI-Public: 00894046001882
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2023

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 Model Number: BMB-EA001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown