FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2083292
·
Received May 10, 2011
Report
- Report Number
- 2531779-2011-03286
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Report Date
- April 13, 2011
- Manufacturer
- ANIMAS CORPORATION
- 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 RESULTS OF THE INVESTIGATION WERE AS NOTED: THE KEYPAD APPEARED INTACT WITH NO LIFTING OR PEELING OBSERVED, THE PUMP WAS INTERMITTENTLY RESPONDING TO ALL KEYPAD BUTTONS, AND THERE WAS EVIDENCE OF ADHESIVE/CONTAMINATION FOUND UNDER ALL KEY CONTACTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE KEYPAD BUTTON PRESSES DID NOT ACTIVATE DESIRED PUMP FUNCTIONS. THE PATIENT CLAIMED THE KEYPAD WAS INTERMITTENTLY UNRESPONSIVE FOR PAST MONTH AND REPORTEDLY HAD TO PRESS BUTTONS SEVERAL TIMES FOR A RESPONSE. THE PATIENT REPORTED THAT KEYPAD IS INTACT AND THE BUTTONS FEEL NORMAL. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION | ONETOUCH PING INSULIN PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 |