FDA Adverse Event
Injury
Summary report: N
CLEO® 90 INFUSION SET
MDR report key: 6852835
·
Received September 8, 2017
Report
- Report Number
- 3012307300-2017-01997
- Event Type
- Injury
- Date Received
- September 8, 2017
- Report Date
- September 8, 2017
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- UDI-DI
- 10610586028335
- PMA / PMN Number
- K042172
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SEE MFR: 3012307300-2017-02035, 3012307300-2017-02036, 3012307300-2017-02037, 3012307300-2017-02038, 3012307300-2017-02039, 3012307300-2017-02040, 3012307300-2017-020341, 3012307300-2017-02042, 3012307300-2017-02043. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE SITE ISSUES WITH A CLEO® 90 INFUSION SET. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE 33.3 MMOL AT THE TIME OF THE EVENT. THERE WERE NO ALARMS INDICATING RISING BLOOD GLUCOSE LEVELS. THE PATIENT ALSO EXPERIENCED VOMITING, AND VISITED THE HOSPITAL. A PROBLEM WITH THE PATIENT'S PUMP WAS RULED OUT AS THE PUMP WAS "WORKING FINE". NO PERMANENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631607 | CLEO® 90 INFUSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. | 77X028 | 10610586028335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Other |