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

Model Number	TM0009
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient contacted customer support due to difficulty powering on their blood glucose meter.Troubleshooting was performed via telephone and a faulty charger was found to be the likely cause of the alleged issue.A replacement charger was issued and only the suspected charger was returned to philips for evaluation.Inspection of the returned charger found the plastic and adhesive near the usb-c connector had melted.The charger would not fit into a known functional meter due to melted adhesive covering the usb-c connector.Testing of the suspected charger confirmed that when connected to a power source, the usb-c connector quickly reached elevated temperatures.The charger will be sent to vendor for further analysis to determine root cause of the charger failure.After shipment of the replacement charger, a follow-up call was made to the patient.To date, the patient has not responded or contacted customer support for further inquiries.Reading transmission records for the affected blood glucose meter show daily transmission of new test results following delivery of the replacement charger.This demonstrates that the device successfully charges and powers on when connected to a different charger with no indication of device malfunction.
Event or Problem Description
Patient alleged that their blood glucose meter would not charge, and that the charger got hot while plugged in.No additional information was provided by the patient and no injury or property damage was alleged.
Additional Manufacturer Narrative
The affected charger was sent to vendor for additional root cause analysis.Vendor investigation concluded that excessive heating of the usb-c connector was caused by liquid spilled into the connector and is attributed to end-user misuse.

• 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: julie doherty ; 600 west ridge road; linwood, PA 19061
• MDR Report Key: 20049889
• Report Number: 3008514395-2024-00008
• Device Sequence Number: 15427923
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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: 08/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2022
• 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: 68 YR
• Patient Sex: Unknown