FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT
MDR report key: 1250023
·
Received November 14, 2008
Report
- Report Number
- 2183996-2008-01739
- Event Type
- Malfunction
- Date Received
- November 14, 2008
- Date of Event
- October 31, 2008
- Report Date
- November 3, 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
ON (B) (6) 2008 THE PATIENT REPORTED THE DISPLAY SCREEN OF HIS INSULIN INFUSION DEVICE IS BROKEN. HE STATED HE NOTICED THIS ON (B) (6) 2008 AND IMMEDIATELY SWITCHED TO HIS BACKUP INFUSION DEVICE. HE SAID THE DISPLAY LOOKS "CRACKED" AND HE CAN NOT READ IT. HE STATED THE DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO WATER. THE PATIENT TRIED ANOTHER BATTERY BUT HE STILL COULD NOT READ THE DISPLAY. NO BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE WERE REPORTED. THE PATIENT DID NOT REQUIRE 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 | 25 YR | INSULIN| INSULIN INFUSION SET |