FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC INSULIN PUMP 670G
MDR report key: 16844440
·
Received April 28, 2023
Report
- Report Number
- MW5117158
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Report Date
- April 26, 2023
- Manufacturer
- MEDTRONIC MINIMED, INC.
- Product Code
- OZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
MEDTRONIC INSULIN PUMP MMT-1780KL NOTIFICATION TO INSPECT BATTERY CAP SHOWED DAMAGE TO ONE OF THREE BATTERY CONTACT POINTS. NO ADVERSE EFFECTS SO FAR AND PUMP ONLY ON STANDBY LAST TWO MONTHS. REPLACEMENT BATTERY CAP PROVIDED BY MEDTRONIC INSTALLED, OLD CAP REMOVED (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1533636 | MEDTRONIC INSULIN PUMP 670G | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC MINIMED, INC. | MMT-1780 KL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | NOVOLOG |