FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK RAPID D
MDR report key: 2070995
·
Received April 20, 2011
Report
- Report Number
- 2183996-2011-01132
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- March 24, 2011
- Report Date
- March 25, 2011
- Manufacturer
- ROCHE INSULIN DELIVERY SYSTEMS INC.
- Product Code
- FPA
- PMA / PMN Number
- K003977
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT'S MOTHER REPORTED, THE PT WAS TAKEN TO THE EMERGENCY ROOM DUE TO AN INFECTION CAUSED BY THE INFUSION SET CANNULA. THE INFECTION WAS NOTICED 36 HOURS AFTER USE. THE PT RECEIVED AN ULTRASOUND IN THE HOSPITAL. HE WAS NOT ADMITTED AND WAS SENT HOME WITH AN ORAL ANTIBIOTIC. NO BLOOD GLUCOSE ISSUES WERE REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK RAPID D | INSULIN INFUSION SET | FPA | ROCHE INSULIN DELIVERY SYSTEMS INC. | NA | 32094360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention | INSULIN| INSULIN INFUSION PUMP |