FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 2071250
·
Received April 27, 2011
Report
- Report Number
- 2531779-2011-02944
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 28, 2011
- Report Date
- March 28, 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
AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. (B)(6). (B)(4).
Additional Manufacturer Narrative · 1
FOLLOW-UP # 1 06/21/2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/23/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX HISTORY CONFIRMED MULTIPLE POWER LOSS EVENTS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT SELF-REBOOTING OCCURING.
Description of Event or Problem · 1
THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO AN ALLEGED SELF-REBOOT ISSUE. THE ANIMAS INSULIN PUMP ALLEGEDLY REBOOTED DAILY. THERE WAS NO REPORT OF PRODUCT MISUSE. THE BATTERY CAP WAS REPLACED BUT THE ISSUE PERSISTED. 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 | 14 YR |