FDA Adverse Event
Malfunction
Summary report: N
System, test, blood glucose, over the counter
MDR report key: 24242799
·
Received February 2, 2026
Report
- Report Number
- 3004130086-2026-00002
- Event Type
- Malfunction
- Date Received
- February 2, 2026
- Date of Event
- July 29, 2025
- Report Date
- February 3, 2026
- Product Code
- NBW
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
CUSTOMER COMPLAINED THAT THE METER HAS A ERR MESSAGE PROBLEM.. (MODEL EMN) MANUFACTURING RECORDS WILL BE REVIEWED RIGHT AFTER RECEIVING THE SERIAL NUMBER AND OTHER DEVICE INFORMATION. THE DEVICE IS NOT RETURNED YET. RELEVANT INVESTIGATION WILL BE INITIATED AFTER RECEIVING THOSE INFORMATION. THE USER HAS NOT YET PROVIDED THE NONCONFORMING METER OR RELATED INFORMATION. THE FIELDS FOR LOT OR BATCH NUMBER, SERIAL NUMBER, AND MANUFACTURING DATE CANNOT BE FILLED IN. IF THE USER PROVIDES THE RELEVANT INFORMATION LATER, IT WILL BE FILLED IN ACCORDINGLY.
Description of Event or Problem · 0
THIS SUBMISSION IS A FOLLOW-UP REPORT FOR MFR REPORT NUMBER: 3004130086-2025-00009 (FILE NAME: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 17086 | System, test, blood glucose, over the counter | NBW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |