FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 1030562
·
Received April 15, 2008
Report
- Report Number
- 2183996-2008-00544
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- April 10, 2008
- Report Date
- April 10, 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
- DE, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IN 2008, THE PATIENT REPORTED THAT HE CHANGED HIS INSULIN CARTRIDGE THE PREVIOUS DAY AND NOW HAD AN AIR BUBBLE IN IT. HE WAS ASSISTED WITH PRIMING THE BUBBLE OUT OF THE INSULIN CARTRIDGE. HE STATED THAT HE USES INSULIN AT ROOM TEMPERATURE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK SPIRIT CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | DISETRONIC MEDICAL SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INSULIN INFUSION SET| INSULIN| INSULIN INFUSION PUMP |