FDA Adverse Event
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1874688
·
Received October 15, 2010
Report
- Report Number
- 2531779-2010-01682
- Date Received
- October 15, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 16, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS AFTER THE KEYPAD WAS REMOVED. CONTAMINATION WAS OBSERVED UNDER THE BUTTONS DURING INVESTIGATION. THE KEYPAD WAS PEELING AT THE OK BUTTON. THE BUTTONS WERE RESPONSIVE AND SPRINGING BACK NORMALLY. DATE OF BIRTH IS UNKNOWN.
Description of Event or Problem · 1
THE DISTRIBUTOR CONTACTED ANIMAS ALLEGING THAT THE PUMP WAS INTERMITTENTLY NOT RESPONDING TO BUTTON PRESSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANIMAS INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ANIMAS 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |