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	Dizziness (2194)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient alleged that their biotel blood glucose meter returned readings that were too high causing them to administer too much insulin and become lightheaded.No serious injury was reported and the patient did no seek medical attention.
Additional Manufacturer Narrative
Device readings history was reviewed via online portal.The allegedly inaccurate results reported by the patient could not be confirmed as the online portal contained no readings logged on or after the date of the alleged event.Device readings history did not contain any record of control solution tests performed on the device.When the patient contacted customer support about their issue, control solution tests could not be performed because no control solution was available.Investigation remains open at this time as the patient has indicated intent to return the affected device, but it has not yet been received.
Event or Problem Description
Patient alleged that their biotel blood glucose meter returned readings that were too high causing them to administer too much insulin and become lightheaded.No serious injury was reported and the patient did not seek medical attention.
Additional Manufacturer Narrative
Patient was contacted three times to request return of the affected device and all outreach attempts were unsuccessful as no return was received.Device readings history was reviewed via online portal.No readings from the date of the alleged event were available as the patient had previously opted out of the program and no longer had an active account.Inspection of available device readings found no evidence of inconsistent back-to-back results.No record of control solution tests was found, and the patient did not have control solution available to complete tests during the troubleshooting call.Device manufacturing records were reviewed, and no contributing factors were found.Based on this investigation, there was insufficient evidence to confirm that the alleged issue occurred, but a potential device problem could not be excluded.

• 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: 21451993
• Report Number: 3008514395-2025-00003
• Device Sequence Number: 15276292
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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: 70 YR
• Patient Sex: Male