FDA Adverse Event
Injury
Summary report: N
MINMED QUICK SET
MDR report key: 19736816
·
Received July 13, 2024
Report
- Report Number
- 3003442380-2024-14406
- Event Type
- Injury
- Date Received
- July 13, 2024
- Date of Event
- June 7, 2024
- Report Date
- May 28, 2026
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244017573
- PMA / PMN Number
- K160648
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
PATIENT CITY: (B)(6)
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN GERMANY. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO HYPOGLYCEMIA OF 1.7 MMOL/L. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 833689 | MINMED QUICK SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL A/S | MMT-397A | UNKNOWN | 05705244017573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |