FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 2072704
·
Received March 31, 2011
Report
- Report Number
- 2531779-2011-02130
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- February 1, 2011
- Report Date
- March 4, 2011
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 REVEALED THAT ALL KEYPAD BUTTONS ARE INTERMITTENTLY RESPONSIVE. THERE WAS EVIDENCE OF KEYPAD ADHESIVE 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, DOWN ARROW, AND OK KEYPAD BUTTONS HAVE BEEN SLOW TO RESPOND FOR THE PAST FEW WEEKS. SHE NOTED THAT THE BUTTONS DO NOT CLICK AS EXPECTED WHEN PRESSED. THE PATIENT CONFIRMED THAT THE RUBBER KEYPAD IS INTACT; DENIED EXPOSING THE PUMP TO MOISTURE; AND STATED THAT SHE WEARS THE PUMP IN HER POCKET OR 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 | 38 YR |