FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK SPIRIT CARTRIDGE
MDR report key: 1055823
·
Received June 2, 2008
Report
- Report Number
- 2183996-2008-00802
- Event Type
- Injury
- Date Received
- June 2, 2008
- Date of Event
- May 23, 2008
- Report Date
- May 23, 2008
- Manufacturer
- DISETRONIC MEDICAL SYSTEMS
- Product Code
- LZG
- PMA / PMN Number
- K060876
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 HER BLOOD GLUCOSE WAS ELEVATED (482 MG/DL) DUE TO AN AIR BUBBLES IN HER INSULIN CARTRIDGE AND INFUSION TUBING. HER NORMAL BLOOD GLUCOSE RANGE IS 180-380 MG/DL. THE PATIENT WAS ABLE TO PRIME THE AIR BUBBLES FROM THE SYSTEM. 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 | Required Intervention | INSULIN| INSULIN INFUSION PUMP| INSULIN INFUSION SET |