FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1833153
·
Received September 9, 2010
Report
- Report Number
- 2531779-2010-01219
- Event Type
- Injury
- Date Received
- September 9, 2010
- Date of Event
- August 6, 2010
- Report Date
- August 9, 2010
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS REVIEWED BY A FAMILY MEMBER AND IT WAS REPORTED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. UPON EXAMINATION, THE CURRENT CARTRIDGE WAS FILLED WITH AIR BUBBLES. FAMILY MEMBER REPORTED THAT THE PATIENT HAD RECENTLY BEGUN TO FILL THE CARTRIDGES WITHOUT ADULT SUPERVISION. NO REPORTS OF BLOOD GLUCOSE EXCURSIONS HAVE BEEN REPORTED SINCE THIS DISCOVERY. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS AND DKA. BLOOD GLUCOSE WAS 460 MG/DL AT TIME OF ADMISSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Hospitalization |