FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 1874115
·
Received October 15, 2010
Report
- Report Number
- 2531779-2010-01715
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- August 8, 2010
- Report Date
- September 22, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS RETURNED TO ANIMAS. A LEAK TEST WAS PERFORMED DURING EVAL AND AIR BUBBLES FORMED NEAR THE PLUNGER AREA OF THE CARTRIDGE. THE PLUNGER WAS REMOVED FROM THE CARTRIDGE AND A CRACKED/DAMAGED FRONT O-RING WAS FOUND ON THE PLUNGER.
Description of Event or Problem · 1
THE PATIENT REPORTED INSULIN IN THE CARTRIDGE COMPARTMENT. THE PATIENT MENTIONED ELEVATED BLOOD GLUCOSE LEVELS OF 500 MG/DL AND 300 MG/DL, BUT DENIED PRESENCE OF KETONES AND DID NOT MENTION ANY SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN CARTRIDGE | INSULIN CARTRIDGE | LZG | ANIMAS CORP. | IR 1200 / 1250 / 2020 / OTP | B201493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |