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	Loss of consciousness (2418)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for inspection and evaluation.No external device damage was identified.Device logs were reviewed and no result of 575 mg/dl results in the 40s as alleged by the patient were found to be stored on the meter.Control solution testing was performed using control solution and test strips and no device inaccuracy was identified.Patient follow-up has been requested for additional information regarding the event.
Event or Problem Description
Patient allegedly checked their blood sugar using the philips blood glucose meter and got a result of 575 mg/dl.Patient then allegedly self-administered insulin and lost consciousness and fell.After the event, the patient alleges their blood glucose was in the low 40s.No medical attention was sought by the patient.The date/time of the alleged event is not known at this time.
Event or Problem Description
Patient allegedly checked their blood sugar using the philips blood glucose meter and got a result of 575 mg/dl.Patient then allegedly self-administered insulin and fell.After the event, the patient alleges their blood glucose was in the low 40s.No medical attention was sought by the patient.The date/time of the alleged event is not known at this time.
Additional Manufacturer Narrative
Patient was contacted on (b)(6) 2024 for additional information concerning the alleged event.The patient stated that the alleged event occurred in (b)(6) 2024 but did not know the specific date.The patient also clarified that they fell but did not lose consciousness.

• 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: 20848872
• Report Number: 3008514395-2024-00009
• Device Sequence Number: 17103512
• 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): 12/23/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TM0009
• Device Catalogue Number: TM0009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown