FDA Adverse Event
Injury
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1861926
·
Received October 4, 2010
Report
- Report Number
- 2531779-2010-01445
- Event Type
- Injury
- Date Received
- October 4, 2010
- Date of Event
- September 6, 2010
- Report Date
- September 6, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE PT'S BLOOD GLUCOSE WAS "HIGH" WHEN HE TESTED ON THE METER REMOTE AFTER GETTING OCCLUSION ALARMS ON HIS PUMP. THE ANIMAS REP EXPLAINED WHAT THE OCCLUSION ALARMS MEANT AND ADVISED THE PT TO CHANGE OUT HIS INFUSION SITE/SET AND TO CLOSELY MONITOR HIS BLOOD GLUCOSE. THE NEXT DAY, THE ANIMAS REP FOLLOWED UP WITH THE PT: THE PT CHANGED THE INFUSION SITE/SET AS INSTRUCTED AND TOOK A CORRECTION DOSE. IT WAS NOTED THAT THE PT'S BLOOD GLUCOSE WENT DOWN TO 153 MG/DL. THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |