MAUDE Adverse Event Report: TELCARE LLC CONNECTED BLOOD GLUCOSE MONITORING SYSTEM; CONNECTED BLOOD GLUCOSE METER

Model Number	TM0009
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device was returned to philips for evaluation without the associated charger.The alleged battery acid leakage was not confirmed as the philips bgm 4 batteries contain a small amount of electrolyte but no acid.Furthermore, inspection of the device interior found evidence of water ingress via corrosion and the moisture exposure indicator on the device battery.Based on this information, it was determined that the device was subjected to unintended environmental conditions.Though the alleged issue was not confirmed, evaluation found charging port components were slightly melted indicating that excessive heating occurred.Excessive heating was determined to be caused by ingress of moisture leading to a short while charging the device.
Event or Problem Description
Patient alleged that their device leaked battery acid.There was no allegation of serious injury, and no medical attention was sought.Return evaluation of the affected device did not confirm the alleged issue but found that the device charging port had melted components indicative of excessive heating at the charging port.

• Brand Name: CONNECTED BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: CONNECTED BLOOD GLUCOSE METER
• Manufacturer (Section D): TELCARE LLC; 600 west ridge road; linwood PA 19061
• Manufacturer (Section G): TELCARE LLC; 600 west ridge road; linwood PA 19061
• Manufacturer Contact: tahnee mehta ; 600 west ridge road; linwood, PA 19061
• MDR Report Key: 24246642
• Report Number: 3008514395-2026-00002
• Device Sequence Number: 21230813
• Product Code: NBW
• UDI-Device Identifier: 00859519002407
• UDI-Public: (01)00859519002407
• Combination Product (Y/N): N
• PMA/510(K) Number: K110571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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 Model Number: TM0009
• Device Catalogue Number: TM0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female