FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 1033518
·
Received April 23, 2008
Report
- Report Number
- 2183996-2008-00578
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- April 16, 2008
- Report Date
- April 16, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PT REPORTED THAT, WHILE INSERTING A NEW CARTRIDGE OF INSULIN IN HIS INFUSION DEVICE, HE NOTICED INSULIN IN THE CARTRIDGE COMPARTMENT. HE STATED IT LOOKED LIKE THE CARTRIDGE HAD LEAKED. HE SAID, HE REMOVED THE CARTRIDGE AND, WHEN HE DID, THE PLUNGER REMAIN ATTACHED TO THE PISTON ROD WHICH CAUSED ALL OF THE INSULIN IN THE CARTRIDGE TO SPILL INTO THE COMPARTMENT. THE PT WAS ADVISED TO SWITCH TO HIS BACKUP DEVICE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | DISETRONIC MEDICAL SYSTEMS | NA | 570387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION PUMP| INSULIN| INSULIN INFUSION SET |