FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1879872
·
Received October 14, 2010
Report
- Report Number
- 2531779-2010-01606
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 14, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MOST RECENT PRIME, ALARM, AND SUSPEND ENTRIES WERE FOUND IN THE HISTORY MENU AS EXPECTED. THE NEXT MOST RECENT ENTRY FOR EACH CATEGORY HAD THE DEFAULT DATE AND TIME ((B)(6) 2007 12:00 AM) WITHOUT ADDITIONAL INFO. A FAMILY MEMBER REPORTED THAT THE PT HAD BEEN WEARING THIS PUMP SINCE (B)(6) 2010, WITHOUT NOTICE OF ANY ISSUE WITH THE HISTORY RECORDS.
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 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR |