MAUDE Adverse Event Report: TELCARE, LLC BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM

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	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Control solution test was performed via telephone with the patient.Control solution test results were within the specified range.Device return has been requested from the patient.Follow up report will be sent upon investigation results.
Event or Problem Description
Patient checked blood sugar using the biotel care blood glucose meter and got a result of 246 mg/dl.Patient took 2 units of insulin and ended up passing out on the floor.Patient was taken by ambulance to the hospital to stay overnight.
Additional Manufacturer Narrative
The device was returned for evaluation and inspection.No external device damage was identified.The battery was found to be slightly swollen.However, this did not affect the operation of the device.Control solution testing was performed using control solution and test strips.No device inaccuracy was identified.

• Brand Name: BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: BIOTEL CARE BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): TELCARE, LLC; 600 west ridge road; linwood PA 19061
• Manufacturer (Section G): TELCARE, LLC; 600 west ridge road; linwood PA 19601
• Manufacturer Contact: julie doherty ; 600 west ridge road; linwood, PA 19601 ; 4845312011
• MDR Report Key: 17011161
• Report Number: 3008514395-2023-00001
• Device Sequence Number: 18015641
• Product Code: NBW
• UDI-Device Identifier: 00859519002407
• UDI-Public: 00859519002407
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Other
• Patient Sex: Male