FDA Adverse Event
Injury
Summary report: N
PUMP MMT-522NAS PRDGM INS V2.2 SK EN
MDR report key: 1771981
·
Received July 22, 2010
Report
- Report Number
- 3004209178-2010-82131
- Event Type
- Injury
- Date Received
- July 22, 2010
- Date of Event
- July 7, 2010
- Report Date
- July 7, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE NURSE FROM HANOVER ENDOCRINOLOGY REPORTED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS HIGH. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization |