FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2103027
·
Received May 25, 2011
Report
- Report Number
- 2531779-2011-03700
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- February 25, 2011
- Report Date
- April 26, 2011
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PUMP WAS RETURNED TO ANIMAS. ON (B)(6) 2011 EVALUATION REVEALED A BROKEN SOLDER TRACE ON A FORCE SENSOR PIN. REVIEW OF THE PUMP DOWNLOAD HISTORY REVEALED LOSS OF PRIME ALARMS ASSOCIATED WITH ZERO FORCE. THE PUMP WAS EXERCISED WITH NO LOSS OF PRIME WARNINGS DUPLICATED. THE PUMP WAS REWOUND, LOADED, PRIMED AND EXERCISED WITH NO ALARMS OCCURRING. THE FORCE SENSOR WAS OUT OF CALIBRATION.
Description of Event or Problem · 1
EVALUATION REVEALED A BROKEN SOLDER TRACE ON A FORCE SENSOR PIN. THERE WAS NO REPORTED PATIENT IMPACT 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 | 52 YR |