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

Model Number	TM0009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient called 911 after receiving a very high result on their blood glucose meter.When the paramedics arrived at the patient's home, they tested the patient's blood glucose with a different device and received a result 60 points lower than that returned by the patient's meter.The patient did not indicate whether the compared readings were taken within 15 minutes of one another and the specific values of the compared results were not provided.The patient did not indicate whether they performed control solution tests on their meter to verify device.The patient did not allege injury and did not provide specific details regarding assistance provided by paramedics or whether treatment was administered.
Additional Manufacturer Narrative
Following the alleged event, the patient called customer support.Customer support attempted to perform troubleshooting and run control solution tests via telephone with the patient, but the patient refused troubleshooting and requested a replacement device.A review of reading logs transmitted by the affected device was performed.Device records showed three l1 control solution tests and zero l2 control solution tests logged by the meter.All l1 control solution test results were within the specified range.No evidence of back-to-back readings more than 15% apart on the affected device was found.Device records show patient blood glucose levels were frequently in the 300s and 400s.Based on this information, it was determined that the device functioned per specification and as intended by alerting the patient to elevated blood glucose levels.Though there is no evidence or allegation of health impact to the patient, this event is being reported out of an abundance of caution due to the patient calling 911 and receiving emergency medical assistance.The patient was contacted more than three (3) times after the event to request additional information and return of the affected device.To date, the patient has not responded, and the affected device has not been received for evaluation.

• 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: 19934584
• Report Number: 3008514395-2024-00007
• Device Sequence Number: 4876258
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: 07/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown