FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INSIGHT PUMP
MDR report key: 5233186
·
Received November 18, 2015
Report
- Report Number
- 3011393376-2015-05147
- Event Type
- Malfunction
- Date Received
- November 18, 2015
- Date of Event
- October 30, 2015
- Report Date
- August 5, 2025
- Manufacturer
- SANMINA CORPORATION
- Product Code
- LZG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). 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 DEVICE SHUT OFF WITHOUT FIRST PROVIDING AN ERROR OR ALERT MESSAGE. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764600 | ACCU-CHEK ® INSIGHT PUMP | INSULIN INFUSION PUMP | LZG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |