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

Model Number	TM0009
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Overheating charger issue was not reported by the patient and was identified after it was returned due to an allegation that it would not charge the device battery.The bgm associated with the faulty charger (serial number (b)(6) was found to be unrelated to the overheating charger issue.The patient was sent a replacement charger and no further problems have been alleged.Online portal records show the device has successfully transmitted blood glucose logs following charger replacement.Product manufacturing records were reviewed and no contributing factors were found.Initial investigation found the overheating was likely the result of a short in the charger usb-c connector.Charger will be returned to the original manufacturing facility for further investigation and to confirm the suspected root cause.
Event or Problem Description
Patient alleged that the charger for their biotel bgm would not charge their device.There was no allegation or evidence of injury or medical attention sought by the patient, and no additional information was provided.When the charger was returned for evaluation, the plastic on the usb-c connector was found to be melted.
Additional Manufacturer Narrative
Overheating charger issue was not reported by the patient and was identified after it was returned due to an allegation that it would not charge the device battery.The bgm associated with the faulty charger (serial number tf100484) was found to be unrelated to the overheating charger issue.The affected charger was returned to the original supplier for additional investigation.Supplier investigation found liquid had made its way into the usb-c connector of the charger leading to a short and causing it to overheat.Issue is attributed to use error as charger is not intended to be exposed to liquid.

• 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: 23033369
• Report Number: 3008514395-2025-00005
• Device Sequence Number: 18505343
• 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): 12/12/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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: 70 YR
• Patient Sex: Unknown