FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT
MDR report key: 3994404
·
Received August 8, 2014
Report
- Report Number
- 1823260-2014-06047
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- July 27, 2014
- Report Date
- September 12, 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) LAW DOESN'T ALLOW PRODUCT RETURN
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 CANNOT BE RETURNED FOR LEGAL AND CUSTOMS ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469072 | ACCU-CHEK ® SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 021 YR |