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

Model Number	TM0009
Medical Device Problem Codes	Material Fragmentation (1261); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, a compliance call was made to check in on the patient because no new blood glucose readings were being transmitted from their device.When the patient answered, they stated that they hadn't been using their blood glucose meter because in october the battery in the device exploded and tore the device apart to the point it was not usable.The patient was not able to provide the specific date of the event.The patient indicated that they had disposed of their device after the event.No injury was reported and no medical attention was sought by the patient.
Additional Manufacturer Narrative
Telcare llc was not made aware of the event until (b)(6) 2024 when a health coach reached out to the patient to ensure they were testing their blood glucose regularly.The patient stated that the device was thrown away and will not be returned for evaluation.When the patient was contacted for follow-up questions, they stated that the device was powered on and connected to a charger when the event occurred.The device history record was reviewed and no non-conformances were found.

• 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: 18631901
• Report Number: 3008514395-2024-00002
• Device Sequence Number: 20856120
• Product Code: NBW
• UDI-Device Identifier: 00859519002407
• UDI-Public: 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2024

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Unknown