FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522WWB PRDGM INSULIN BL EN US
MDR report key: 1845051
·
Received September 13, 2010
Report
- Report Number
- 3004209178-2010-82750
- Event Type
- Malfunction
- Date Received
- September 13, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 3, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK 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 INSULIN PUMP WAS NOT DELIVERING ALL THE INSULIN. IT WAS STATED THAT THE CUSTOMER HAS BEEN USING MANUAL INJECTIONS FOR A FEW WEEKS. THE NURSE REQUESTED A REPLACEMENT INSULIN PUMP. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522WWB PRDGM INSULIN BL EN US | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522WWB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |