FDA Adverse Event
Malfunction
Summary report: N
MINIMED QUICK-SET
MDR report key: 19590581
·
Received June 22, 2024
Report
- Report Number
- 3003442380-2024-09709
- Event Type
- Malfunction
- Date Received
- June 22, 2024
- Date of Event
- May 23, 2024
- Report Date
- June 22, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244017573
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1894173 - MDR 3003442380-2024-09709- DEVICE 3 OF 4 E1: PATIENT CITY:(B)(6)PATIENT COUNTRY: (B)(6)
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET LEAKE EVENTS ON (B)(6)2024. THE INFUSION SET WAS IN USE FOR ONE DAY. THE LEAK WAS AT THE SITE. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1115417 | MINIMED QUICK-SET | UNO QUICK-SET 60/6 SC1 MECA | FPA | UNOMEDICAL A/S | MMT-397A | UNKNOWN | 05705244017573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |