FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3853200
·
Received June 6, 2014
Report
- Report Number
- 1823260-2014-04116
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 19, 2014
- Report Date
- July 17, 2014
- Manufacturer
- ACCU-CHEK ® SPIRIT COMBO
- 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
(B)(4). THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE SPOTS ON THE DISPLAY OF THE PATIENT'S INFUSION DEVICE. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332735 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ACCU-CHEK ® SPIRIT COMBO | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 048 YR |