FDA Adverse Event
Malfunction
Summary report: N
MINIMED QUICK-SET
MDR report key: 19465093
·
Received June 4, 2024
Report
- Report Number
- 3003442380-2024-05904
- Event Type
- Malfunction
- Date Received
- June 4, 2024
- Date of Event
- May 4, 2024
- Report Date
- June 4, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244017573
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
(B)(6).
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT INFUSIONS SET WAS LEAKING FROM ITS SITE. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1524996 | MINIMED QUICK-SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL A/S | MMT-397A | 6002388 | 05705244017573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |