FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 4243602
·
Received November 11, 2014
Report
- Report Number
- 1823260-2014-08769
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Date of Event
- October 16, 2014
- Report Date
- January 29, 2015
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LZG
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
REPORTER STATED THERE ARE BLACK SPOTS IN THE MIDDLE OF THE INFUSION DEVICE DISPLAY. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727067 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 038 YR |