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

Model Number	TM0009
Medical Device Problem Codes	Failure to Charge (1085); Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient reported they were unable to turn on or charge the device but did not allege injury or device damage.The device was returned for evaluation and inspection.The device was not operational, and inspection found that the battery cover was slightly melted.When the battery cover was removed, a corner of the battery and a portion of the battery port were found to be burned/melted.Patient reported they were unable to turn on or charge the device but did not allege injury or device damage.The device was returned for evaluation and inspection.The device was not operational, and inspection found that the battery cover was slightly melted.When the battery cover was removed, a corner of the battery and a portion of the battery port were found to be burned/melted.
Additional Manufacturer Narrative
Patient only reported that the device in question would not power on or charge.Philips was not made aware of a reportable issue until the malfunctioning device was returned for inspection and battery damage was observed.The device has been sent to original supplier for further analysis to determine root cause of battery damage/failure.
Additional Manufacturer Narrative
Device was sent to vendor for further analysis to determine root cause of battery damage/failure.The vendor was unable to establish a definitive root cause and concluded that the probable cause was use of a non-compatible charger adapter.

• 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 ; 4845312011
• MDR Report Key: 17279043
• Report Number: 3008514395-2023-00002
• Device Sequence Number: 3566664
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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
• Date Returned to Manufacturer: 06/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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: 43 YR
• Patient Sex: Unknown