FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE
MDR report key: 6110766
·
Received November 17, 2016
Report
- Report Number
- 3011393376-2016-07416
- Event Type
- Malfunction
- Date Received
- November 17, 2016
- Date of Event
- November 6, 2016
- Report Date
- February 6, 2017
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- KZH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY. NO ADVERSE EVENT REPORTED. THE DEVICE LOT NUMBER WAS NOT PROVIDED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761319 | ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE | SPRING LOADED INSERTION DEVICE | KZH | ROCHE DIABETES CARE, INC. | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |