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

Model Number	TM0009
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported a concern that their blood glucose meter was not accurate after obtaining back-to-back blood test results that were over 200 points different.While on the phone with a customer service representative, the patient took three blood tests within 6 minutes and received results of 273 mg/dl, 402 mg/dl, and 142mg/dl.Additionally, three level 1 and three level 2 control solution tests were performed via telephone with the patient.One of the level 2 test results was out of the specified range.No symptoms or injury were reported, and no self-treatment or medical attention was required.
Additional Manufacturer Narrative
Following the allegation, a review of reading logs transmitted by the affected device was performed.The alleged erratic back-to-back readings and out-of-range level 2 control solution test from the date of the event (b)(6).2023 was confirmed.Additionally, device logs from a day prior to the event ((b)(6).2023) showed back-to-back tests taken 2 minutes apart returned results 360 mg/dl and 91 mg/dl.No other back-to-back readings more than 15% apart and no other out of range control solution test results were found.The device history record was reviewed, and no non-conformances were found.In subsequent communication via telephone, the patient indicated they intend to return the affected product(s) for physical 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: 18505213
• Report Number: 3008514395-2024-00001
• Device Sequence Number: 7900825
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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: 12/15/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Unknown