FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® RAPID-D INFUSION SET
MDR report key: 3944707
·
Received July 18, 2014
Report
- Report Number
- 1823260-2014-05380
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 27, 2014
- Report Date
- August 6, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- FPA
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A LEAK IN THE INFUSION TUBING OF THE PATIENT'S INFUSION SET. THE PATIENT STATED THAT NO INSULIN COMES OUT OF THE END OF THE CANNULA AND THAT SHE CAN SMELL INSULIN. SHE EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS FROM 450 MG/DL TO 550 MG/DL. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422278 | ACCU-CHEK ® RAPID-D INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIAGNOSTICS | NA | 32111413 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 054 YR |