MAUDE Adverse Event Report: TELCARE, LLC BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM

Model Number	TM0008
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case was reviewed by qualified person (health care professional) and deemed to be a device-to-device comparison (cannot validate readings from a non-company device).Control solution testing was performed, with results within range.Patient had no further inquiries or concerns.
Event or Problem Description
Insulin dependent patient communicated reading discrepancy between dexcom cgm and biotel care blood glucose meter.The patient indicated that the dexcom cgm produced a reading of 80 ml/dl, while the biotel care blood glucose meter produced a reading of 200 mg/dl.Telcare customer service attempted to perform control solution testing on the phone with the patient, but the patient's control solution was expired.Telcare customer service overnighted the patient control solution and proceeded to perform a troubleshooting call.Control solution test results (l1 and l2) were both in range.There is no known consequence to the patient and no serious injury was reported.Patient had no further questions or concerns.

• Brand Name: BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): TELCARE, LLC; 600 west ridge road; suite 200; linwood PA 19061
• MDR Report Key: 11205530
• Report Number: 3008514395-2021-00001
• Device Sequence Number: 3966541
• Product Code: NBW
• UDI-Device Identifier: B146C6D10
• UDI-Public: B146C6D10
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2020

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 Expiration Date: 09/08/2022
• Device Model Number: TM0008
• Device Catalogue Number: TM0008
• Device Lot Number: A3S2009001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR