FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE
MDR report key: 6060734
·
Received October 27, 2016
Report
- Report Number
- 3011393376-2016-06970
- Event Type
- Malfunction
- Date Received
- October 27, 2016
- Date of Event
- October 4, 2016
- Report Date
- November 16, 2016
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- LZG
- 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 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
CUSTOMER'S MOTHER ADVISED THE CARTRIDGE WAS LEAKING IN THE PUMP. LOT NUMBER UNKNOWN. 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 |
|---|---|---|---|---|---|---|---|
| 712266 | ACCU-CHEK ® 3.15 ML INSULIN CARTRIDGE | INSULIN INFUSION PUMP ACCESSORY | LZG | ROCHE DIABETES CARE, INC. | AKSU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |