FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19737745
·
Received July 14, 2024
Report
- Report Number
- 3003442380-2024-14155
- Event Type
- Malfunction
- Date Received
- July 14, 2024
- Date of Event
- June 1, 2024
- Report Date
- July 14, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244026032
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1912422 - MDR 3003442380-2024-14155- DEVICE 4 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS FELL OFF EVENTS ON 01-JUN,02-JUN AND 05-JUN-2024. INFUSION SET WAS IN USE FOR 3HRS ON 1-JUNE, LESS THAN 12 HRS ON 2-JUNE AND ABOUT 12 HRS ON 5 JUNE. PATIENT'S BLOOD GLUCOSE WAS 100-180 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1391158 | AUTOSOFT XC | INSET I 2-PACK 60/9 GREY TCAP | FPA | UNOMEDICAL A/S | 1010899 | 6004393 | 05705244026032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male |