FDA Adverse Event
Malfunction
Summary report: N
IACCU-CHEK SPIRIT
MDR report key: 1062260
·
Received June 17, 2008
Report
- Report Number
- 2183996-2008-00863
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 31, 2008
- Report Date
- June 7, 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
- UT, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IN 2008, THE PATIENT'S MOTHER REPORTED THAT THE DISPLAY OF THE PATIENT'S INFUSION DEVICE HAS BLACK SPLOTCHES AND NO LONGER DISPLAYS CHARACTERS. THE INFUSION DEVICE HAS NOT BEEN EXPOSED TO MOISTURE. THE PATIENT'S MOTHER STATED THAT THE BATTERY WAS CHANGED. 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 | IACCU-CHEK SPIRIT | INSULIN INFUSION PUMP | LZG | DISETRONIC MEDICAL SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION SET| INSULIN |