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

Model Number	TM0009
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient has been contacted four (4) times to complete resolution and request device return from the patient.To date, the patient has not responded to outreach attempts.The device history record was reviewed, and no contributing factors were identified.
Event or Problem Description
The patient reported a concern that their blood glucose is not accurate after receiving inconsistent back-to-back readings.Device logs show that on (b)(6) 2024, a series of four (4) blood glucose readings were recorded between 8:36 am and 8:38 am.The results were 69, 79, 107, and 119 respectively.Control solution testing was not performed as the patient did not have control solution.No symptoms or injury were reported, and no medical attention was required.
Additional Manufacturer Narrative
The device was returned for evaluation and inspection.No external device damage was identified.Control solution testing was performed using control solution and test strips.No device inaccuracy was identified.

• 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: 18769106
• Report Number: 3008514395-2024-00004
• Device Sequence Number: 4387429
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: 01/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Unknown