FDA Adverse Event
Malfunction
Summary report: N
ANIMAS INSULIN INFUSION PUMP
MDR report key: 1901626
·
Received November 10, 2010
Report
- Report Number
- 2531779-2010-02226
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Report Date
- October 13, 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 WAS RETURNED TO ANIMAS FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED TO BE INTACT (NO LIFTING OR PEELING), THE PUMP WAS INTERMITTENTLY RESPONDING TO KEYPAD BUTTON PRESSES, THE UP KEY CONTACT WAS MISALIGNED, THE UP AND DOWN KEY CONTACT WERE INVERTED AND MISALIGNED AND DID NOT ALWAYS SPRING BACK, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION UNDER ALL THE KEY CONTACTS.
Description of Event or Problem · 1
ACCORDING TO THE DISTRIBUTOR, THE PT HAS TO PRESS THE BUTTONS SEVERAL TIMES FOR THE PUMP TO RESPOND.
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 |