FDA Adverse Event
Malfunction
Summary report: N
MINIMED QUICK-SET
MDR report key: 19644290
·
Received July 1, 2024
Report
- Report Number
- 3003442380-2024-11292
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Date of Event
- May 25, 2024
- Report Date
- July 2, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244017450
- PMA / PMN Number
- K160648
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(4). IT WAS REPORTED THAT PATIENT FACED INFUSIONS SET TAP NOT STICKING EVENT ON 25-MAY-2024. INFUSION SET FELL OFF DURING SLEEP. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1270956 | MINIMED QUICK-SET | UNO QUICK-SET 60/6 SC1 MECA | FPA | UNOMEDICAL A/S | MMT-399A | UNKNOWN | 05705244017450 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |