FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1872572
·
Received October 8, 2010
Report
- Report Number
- 2531779-2010-01534
- Event Type
- Malfunction
- Date Received
- October 8, 2010
- Date of Event
- September 8, 2010
- Report Date
- September 8, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K042873
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVAL. EVAL REVEALED THAT THE KEYPAD WAS PEELING AT THE "UP" BUTTON. THE KEYPAD BUTTONS WERE REPORTEDLY RESPONSIVE AND SPRINGING BACK NORMALLY. EVIDENCE OF ADHESIVE AND MOISTURE CORROSION WAS OBSERVED UNDER BUTTON CONTACTS. THE KEYPAD WAS OBSERVED TO BE PEELING DURING INVESTIGATION. CONTAMINATION WAS OBSERVED UNDER KEYPAD.
Description of Event or Problem · 1
THE PT ALLEGED THAT A PUMP WAS LESS RESPONSIVE TO PRESSING OF THE UP ARROW BUTTON. THE PT DENIED ANY BG EXCURSION ASSOCIATED WITH PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | IR 2020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR |