MAUDE Adverse Event Report:; System, test, blood glucose, over the counter

Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user has not yet provided the nonconforming meter or related information.Therefore, this case will be temporarily closed.If we receive the meter or related information from the user in the future, the analysis will be restarted.
Event or Problem Description
This submission is a follow-up report for mfr report number: 3004130086-2024-00002 (file name: (b)(4)).

• Common Device Name: System, test, blood glucose, over the counter
• MDR Report Key: 20490930
• Report Number: 3004130086-2024-00013
• Device Sequence Number: 19721099
• Product Code: NBW
• UDI-Device Identifier: 00885017000058
• UDI-Public: 00885017000058
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown