FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1063323
·
Received June 19, 2008
Report
- Report Number
- 2183996-2008-00896
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- June 9, 2008
- Report Date
- June 9, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVAL.
Description of Event or Problem · 1
IN 2008, THE PT REPORTED THAT HE RECEIVED AN E4 (OCCLUSION) ERROR ON HIS INFUSION DEVICE AT 4:20PM. HE STATED THAT HE CHANGED HIS INSULIN CARTRIDGE, INFUSION TUBING, AND INFUSION SITE AND CLEARED THE ERROR. HE STATED THAT AT 4:40PM, HIS BLOOD GLUCOSE WAS ELEVATED TO 223 MG/DL AND HE BOLUSED 2 UNITS OF INSULIN. HIS NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. THE PT DID NOT REQUIRE MEDICAL 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 | Required Intervention | INSULIN INFUSION SET| INSULIN |