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	03/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the allegation, a review of reading logs transmitted by the affected device was performed.It was confirmed that on the date of the event, one out-of-range l2 test result was logged by the device.No evidence of back-to-back readings more than 15% apart and no other out-of-range control solution test results were found.Though the out-of-range result may have been caused by factors other than device malfunction (e.G.User error by incorrectly applying control solution), this event is being reported out of an abundance of caution.The patient was contacted multiple times after the event to request additional information and the return of the affected device.To date, the patient has not responded.
Event or Problem Description
Patient alleged that their blood glucose meter was not accurate after comparing results with a meter from a different manufacturer.The patient performed control solution tests on the device and alleged that one l1 test result and one l2 test result was outside the specified range.There was no allegation of symptoms or injury associated with the event and no treatment or medical attention was sought by the patient.
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: 19076290
• Report Number: 3008514395-2024-00006
• Device Sequence Number: 15178507
• Product Code: NBW
• UDI-Device Identifier: 00859519002407
• UDI-Public: 00859519002407
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/14/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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 Sex: Unknown