FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SPIRIT COMBO
MDR report key: 3884427
·
Received June 19, 2014
Report
- Report Number
- 1823260-2014-04477
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 28, 2014
- Report Date
- July 18, 2014
- 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).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S INFUSION DEVICE WAS DROPPED IN WATER. THE PATIENT STATED THAT THE RUBBER COVERING OF THE UP BUTTON WAS DAMAGED AND AFTER THE CONTACT WITH THE WATER THE DEVICE WAS "DEAD". DURING INITIAL INVESTIGATION, IT WAS FOUND THAT THE UP BUTTON ON THE PATIENT'S INFUSION DEVICE WAS NOT FUNCTIONING. NO ADVERSE EVENT WAS REPORTED. THE INFUSION DEVICE WILL BE SENT FOR FURTHER PRODUCT EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361696 | ACCU-CHEK ® SPIRIT COMBO | INSULIN INFUSION PUMP | LZG | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 043 YR |