FDA Adverse Event
Injury
Summary report: N
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
MDR report key: 1872069
·
Received October 8, 2010
Report
- Report Number
- 2531779-2010-01538
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- September 10, 2010
- Report Date
- September 10, 2010
- Manufacturer
- ANIMAS CORP.
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THROUGH THE INVESTIGATION, THE CDE DETERMINED THAT THE PUMP WAS FUNCTIONING PROPERLY. THE ALARM HISTORY REVEALED AN EMPTY CARTRIDGE AT 10:40 AM THAT MORNING. THE PT CLAIMED THAT SHE WAS UNAWARE THE PUMP WAS EMPTY. SHE ALSO DENIED CHANGING THE CARTRIDGE. THE CDE VERIFIED ON THE HOME SCREEN OF THE PUMP TO HAVE "0" INSULIN.
Description of Event or Problem · 1
THE REPORTER/SCHOOL NURSE ALLEGED A LOSS OF PRIME MESSAGE ISSUE WITH THE PUMP. ACCORDING TO THE REPORTER, THE PT CAME TO HER WITH THE LOSS OF PRIME MESSAGE. IN ADDITION, THE PT WAS REPORTEDLY FOUND TO HAVE "TRACE KETONES", BUT WAS FEELING FINE. HER BLOOD GLUCOSE WAS TESTED ON AN UNIDENTIFIED DEVICE AND A RESULT OF "490 MG/DL" WAS OBTAINED.
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 | 15 YR | Life Threatening |