FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 1163440
·
Received September 10, 2008
Report
- Report Number
- 2183996-2008-01372
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- September 2, 2008
- Report Date
- September 2, 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
- IN, 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 PT REPORTED THAT THERE WAS AN AIR BUBBLE IN HER INSULIN CARTRIDGE. SHE STATED THAT SHE ALLOWS HER INSULIN TO REACH ROOM TEMPERATURE PRIOR TO USE. THERE WERE NO AIR BUBBLES IN THE INSULIN CARTRIDGE PRIOR TO INSERTION. THE PT WAS INSTRUCTED TO PRIME THE AIR FROM THE INSULIN CARTRIDGE. SHE WAS ADVISED TO PROPERLY ADJUST THE PISTON ROD OF THE INFUSION DEVICE, PRIOR TO INSERTING THE INSULIN CARTRIDGE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 | 67 YR | INSULIN INFUSION PUMP| INSULIN| INSULIN INFUSION SET |