FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT
MDR report key: 3931492
·
Received July 14, 2014
Report
- Report Number
- 1823260-2014-05172
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 23, 2014
- Report Date
- July 14, 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). (B)(6) DOESN'T ALLOW PRODUCT RETURN.
Description of Event or Problem · 1
REPORTER STATED THE BUTTONS ON THE INFUSION DEVICE DO NOT FUNCTION. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT CANNOT BE RETURNED FOR EVALUATION DUE TO LEGAL AND CUSTOM ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409596 | ACCU-CHEK ® SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 039 YR |