ACCU-CHEK SPIRIT
Report
- Report Number
- 2183996-2008-01610
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 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
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
NO PRODUCT WILL BE RETURNED FOR EVAL.
ON (B) (6) 2008, THE PT REPORTED HE KEEPS RECEIVING OCCLUSION MESSAGES ON HIS INSULIN INFUSION DEVICE. HE STATED HE HAS CHANGED HIS INFUSION SET, CARTRIDGE, AND BATTERY BUT THE OCCLUSION MESSAGES CONTINUE. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO TAKE OFF ALL ACCESSORIES AND PERFORM A DRY PRIME WHICH HE DID WITHOUT ERROR. THE PT WAS THEN INSTRUCTED TO REINSERT HIS INSULIN CARTRIDGE INTO THE DEVICE. THE PT DID SO AND THE DEVICE IMMEDIATELY GAVE AN OCCLUSION MESSAGE. THE PT STATED THE PISTON ROD DOES NOT APPEAR TO BE DIRTY BUT DURING HIS LAST CARTRIDGE CHANGE, HE DID NOTICE MOISTURE IN THE CARTRIDGE CHAMBER OF HIS DEVICE. THE PT WAS ADVISED TO SWITCH TO HIS BACKUP INFUSION DEVICE AND TO USE THE SAME ACCESSORIES. ON FOLLOW UP WITH THE PT, HE STATED HE SWITCHED BACK TO HIS PRIMARY DEVICE AND HAS HAD NO FURTHER OCCLUSION ALARMS. 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 WILL BE RETURNED FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | INSULIN| INSULIN INFUSION SET |