FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® FLEXLINK PLUS INFUSION SET
MDR report key: 6610563
·
Received June 5, 2017
Report
- Report Number
- 3011393376-2017-03166
- Event Type
- Malfunction
- Date Received
- June 5, 2017
- Date of Event
- May 18, 2017
- Report Date
- July 17, 2017
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- FPA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED OUTSIDE 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. MEDWATCH WITH A1 IDENTIFIER (B)(4) IS LOT 1181892, MEDWATCH WITH A1 IDENTIFIER (B)(4) IS LOT 1184330.
Description of Event or Problem · 1
OFTEN, DIRECTLY AFTER CANNULA CHANGE, THE SELF-ADHESIVE/PLASTER DOES NOT STICK ENOUGH. NO ADVERSE EVENT ALLEGED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392445 | ACCU-CHEK ® FLEXLINK PLUS INFUSION SET | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIABETES CARE, INC. | 1184330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |