FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2063207
·
Received April 12, 2011
Report
- Report Number
- 2531779-2011-02490
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION CONFIRMED THAT ALL BUTTON SYMBOLS ARE WORN, AND THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE TO PRESSES. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL BUTTON KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE. THE PATIENT REPORTED THAT THE UP ARROW KEYPAD BUTTON IS SLOW TO RESPOND TO PRESSES AT TIMES. SHE NOTED THAT THE BUTTON DOES NOT CLICK WHEN PRESSED. THE PATIENT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; STATED THAT THE BUTTON SYMBOLS ARE WORN OFF; DENIED EXPOSING THE PUMP TO MOISTURE; AND STATED THAT SHE WEARS THE PUMP CLIPPED TO HER WAIST.
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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |