FDA Adverse Event
Injury
Summary report: N
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
MDR report key: 1842878
·
Received September 17, 2010
Report
- Report Number
- 3004209178-2010-82845
- Event Type
- Injury
- Date Received
- September 17, 2010
- Date of Event
- July 25, 2010
- Report Date
- September 15, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS, AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED BEING IN THE HOSPITALIZED FOR HIGH BLOOD GLUCOSE. DURING THE CALL, THE CUSTOMER STATED THAT SHE WAS OUT OF SUPPLIES. TROUBLESHOOTING WAS PERFORMED. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE DEVICE PASSED THE TESTS. NO FURTHER INFO 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 | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization |