FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT
MDR report key: 3923645
·
Received July 9, 2014
Report
- Report Number
- 1823260-2014-05059
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- June 1, 2014
- Report Date
- July 23, 2014
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
PATIENT REPORTED THE SIDE BUTTONS OF THE PUMP ARE DAMAGED. PATIENT STATED HE CAN NO LONGER SET HIS INSULIN DOSE. PATIENT REPORTED THE UPPER SIDE BUTTON IS COMPLETELY BROKEN. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED PUMP FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399470 | ACCU-CHEK ® SPIRIT | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 030 YR |