FDA Adverse Event
Malfunction
Summary report: N
CONNECTED BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 17623530
·
Received August 25, 2023
Report
- Report Number
- 3008514395-2023-00003
- Event Type
- Malfunction
- Date Received
- August 25, 2023
- Date of Event
- July 25, 2023
- Report Date
- August 23, 2023
- Manufacturer
- TELCARE, LLC
- Product Code
- NBW
- UDI-DI
- 00859519002407
- PMA / PMN Number
- K110571
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
PATIENT'S AUTHORIZED CONTACT STATED THAT THE AFFECTED DEVICE WAS THROWN AWAY AND WILL NOT BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED BY THE PATIENT OR AUTHORIZED CONTACT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND.
Description of Event or Problem · 0
PATIENT'S AUTHORIZED CONTACT REPORTED THE METER WAS SITTING ON THE COUNTER WHEN THEY OBSERVED THE BACK OF THE DEVICE WAS BUBBLING/MELTING NEAR THE BATTERY. THE AFFECTED DEVICE WAS THROWN AWAY BY THE USER. NO INJURY OR PROPERTY DAMAGE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1803077 | CONNECTED BLOOD GLUCOSE MONITORING SYSTEM | CONNECTED BLOOD GLUCOSE METER | NBW | TELCARE, LLC | TM0009 | 00859519002407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Unknown |