FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 1021481
·
Received March 26, 2008
Report
- Report Number
- 2183996-2008-00387
- Event Type
- Malfunction
- Date Received
- March 26, 2008
- Date of Event
- February 26, 2008
- Report Date
- March 1, 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
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE PT REPORTED HE HAS NOTICED AIR BUBBLES IN THE INSULIN CARTRIDGES OF HIS INFUSION DEVICE. THE PT WAS ADVISED TO PRIME ALL AIR BUBBLES OUT. TROUBLESHOOTING DID NOT FIND ANY PRODUCT OR USER ISSUES. 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. NO PRODUCT WAS 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN| INSULIN INFUSION SET| INSULIN INFUSION PUMP |