FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT
MDR report key: 3884167
·
Received June 19, 2014
Report
- Report Number
- 1823260-2014-04467
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 29, 2014
- Report Date
- July 10, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
REPORTER STATED THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE WORK INTERMITTENTLY AND THE PROTECTIVE RUBBER IS DAMAGED. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360138 | ACCU-CHEK ® SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |