FDA Adverse Event
Malfunction
Summary report: N
INFUSION DEVICES - UNKNOWN
MDR report key: 19678945
·
Received July 5, 2024
Report
- Report Number
- 3003442380-2024-11771
- Event Type
- Malfunction
- Date Received
- July 5, 2024
- Date of Event
- May 2, 2024
- Report Date
- July 5, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- PFA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1903469- MDR 3003442380-2024- 11771- DEVICE 5 OF 5
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6) IT WAS REPORTED THAT PATIENT FACED 5 INFUSION SET WAS FELL OFF DURING USE ON 02-MAY-2024. THE BLOOD GLUCOSE LEVEL WAS 150 MG/DL AT THE TIME OF EVENT. THE INFUSION SET WAS IN USE FOR 2 DAYS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466366 | INFUSION DEVICES - UNKNOWN | INFUSION DEVICES - UNKNOWN | PFA | UNOMEDICAL A/S | INFUSION DEVICES - UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Male |