FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT
MDR report key: 3925553
·
Received July 10, 2014
Report
- Report Number
- 1823260-2014-05077
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- June 20, 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
- RS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT NONE OF THE BUTTONS ON THE INFUSION DEVICE WERE FUNCTIONING. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE CAN NOT BE RETURNED FOR LEGAL AND CUSTOMS ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 403578 | ACCU-CHEK ® SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 015 YR |