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

Model Number	TM0009
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected power cord was returned and evaluated.It was found that the side of the power cord wall adapter cube containing prongs was separated from the rest of the wall adapter cube and separated into two pieces.There was evidence of fracturing between the separated pieces of the wall adapter cube.A review of production records associated with the product found no likely contributing factors.The damaged power cord will be returned to the original supplier for further investigation into likely root cause.
Event or Problem Description
Patient contacted customer support to allege that the power cord for their biotel blood glucose meter was damaged.The patient alleged that the prongs separated from the power cord wall adapter as it was being removed from a wall outlet.There was no allegation of injury, and no medical attention was sought.
Additional Manufacturer Narrative
The affected power cord was returned and evaluated.It was found that the side of the power cord wall adapter cube containing prongs was separated from the rest of the wall adapter cube and separated into two pieces.There was evidence of fracturing between the separated pieces of the wall adapter cube.A review of production records associated with the product found no likely contributing factors.The damaged power cord was returned to the original supplier for further investigation.Supplier investigation concluded that the charger damage was likely the result of degradation from material aging, repeated expansion and contraction fluctuations in temperature while charging, and possible misuse such as dropping the charger.

• 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: 21140068
• Report Number: 3008514395-2025-00001
• Device Sequence Number: 6957956
• 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): 06/02/2025

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
• Device Lot Number: N/
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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: 58 YR
• Patient Sex: Female