FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INSIGHT FLEX
MDR report key: 7934057
·
Received October 4, 2018
Report
- Report Number
- 3011393376-2018-04188
- Event Type
- Malfunction
- Date Received
- October 4, 2018
- Date of Event
- September 24, 2018
- Report Date
- October 4, 2018
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- FPA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
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 INFUSION SET WAS LEAKING AT THE HEADSET. THE CALLER REPORTED THEY HAD TWO BOXES OF INFUSION SETS (LOT 1222197 AND 1223240) AND THEY ARE UNSURE WHICH LOT # PRODUCED THE LEAK. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS DISCARDED; THEREFORE, NO PRODUCT COULD BE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775618 | ACCU-CHEK ® INSIGHT FLEX | SUBCUTANEOUS INFUSION SET | FPA | ROCHE DIABETES CARE, INC. | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |