FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-712 WWB PRDGM INSULIN BL EN PR
MDR report key: 1232056
·
Received November 7, 2008
Report
- Report Number
- 3004209178-2008-00932
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 21, 2008
- Report Date
- October 27, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- 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
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712 WWB PRDGM INSULIN BL EN PR | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-712WWB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |