FDA Adverse Event
Injury
Summary report: N
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
MDR report key: 1932930
·
Received December 14, 2010
Report
- Report Number
- 3004209178-2010-83599
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- October 2, 2010
- Report Date
- December 3, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD ERRATIC HIGH BLOOD GLUCOSE SINCE HAVING THE BABY. IT WAS STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE ON FOUR SEPARATE OCCASIONS. IT WAS STATED THAT THE CUSTOMER HAS BEEN ON MANUAL INJECTIONS SINCE HER LAST ADMISSION. IT WAS STATED THAT HER DOCTOR REQUESTED TO HAVE A REPLACEMENT OF THE INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-715NAS PRDGM INS V2.1 SK EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-715NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Hospitalization |