FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN CARTRIDGE
MDR report key: 2066051
·
Received March 28, 2011
Report
- Report Number
- 2531779-2011-02046
- Event Type
- Injury
- Date Received
- March 28, 2011
- Report Date
- February 26, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K032257
- Removal / Correction Number
- 2531779-02/25/11-001-R
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT # B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.
Description of Event or Problem · 1
THE REPORTER, THE PT'S FATHER, REPORTED THE PT HAD OBTAINED VERY ERRATIC BLOOD GLUCOSE READINGS SINCE (B)(6) 2010, RANGING FROM 40 MG/DL TO 400 MG/DL. THE PT DID NOT REPORT EXPERIENCING ANY SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND DID NOT SEEK ANY MEDICAL ATTENTION. ON AN UNSPECIFIED DATE, THE PT NOTED THE INSULIN CARTRIDGE WAS LEAKING AND THE PUMP'S CARTRIDGE COMPARTMENT WAS WET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN CARTRIDGE | INSULIN INFUSION PUMP CARTRIDGE | LZG | ANIMAS CORPORATION | IR 1200 / 1250 / 2020/ OTP | B201581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |