FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
MDR report key: 1190054
·
Received October 6, 2008
Report
- Report Number
- 3004209178-2008-00817
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- September 28, 2008
- Report Date
- September 28, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
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
CUSTOMER REPORTED BEING HOSPITALIZED FOR HIGH BLOOD GLUCOSE. NO BLOOD GLUCOSE LEVEL WAS PROVIDED AT THE TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED, AND FOUND THAT THE INSULIN PUMP'S TIME WAS OFF. THE CUSTOMER WAS ADVISED OF THE IMPORTANCE OF HAVING ACCURATE TIME IN THE INSULIN PUMP. PERFORMED THE DISPLACEMENT TEST AND THE HIGH PRESSURE AND BOTH PASSED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAS PRDGM INS V2.2 SK EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |