FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1904189
·
Received November 15, 2010
Report
- Report Number
- 2531779-2010-02298
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- October 15, 2010
- Report Date
- October 15, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVAL HAS NOT YET BEEN COMPLETED. WHEN EVAL IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
THE PT REPORTED THAT THE BUTTONS WERE NOT RESPONDING ON THE KEYPAD. THE REPORTER DENIES DAMAGE TO THE KEYPAD OR EXPOSURE TO WATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORP. | ONE TOUCH PING | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |