FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1063142
·
Received June 20, 2008
Report
- Report Number
- 2183996-2008-00933
- Event Type
- Injury
- Date Received
- June 20, 2008
- Date of Event
- May 17, 2008
- Report Date
- June 17, 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
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IN 2008, THE PATIENT REPORTED THAT 1/4 OF THE DISPLAY OF THIS INFUSION DEVICE IS VERY FAINT AND ALMOST IMPOSSIBLE TO READ. HE STATED THAT HE FIRST NOTICED THE ISSUE ONE MONTH AGO. THE INFUSION DEVICE HAS NOT BEEN EXPOSED TO WATER AND HAS NOT BEEN DROPPED. THE DISPLAY IS NOT CRACKED OR BROKEN. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION SET| INSULIN |