FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
MDR report key: 1913704
·
Received November 23, 2010
Report
- Report Number
- 3004209178-2010-83418
- Event Type
- Malfunction
- Date Received
- November 23, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 4, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 THAT THE INSULIN PUMP WAS NOT FUNCTIONING AND HAD A FROZEN DISPLAY. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE FROZEN DISPLAY CONTINUED EVEN AFTER THE BATTERY WAS CHANGED AND THE DEVICE WAS RESTED. ADVISED THE CUSTOMER TO REVERT TO HER BACK UP PLAN AND TO CONTACT HER DOCTOR TO RETRIEVE THE BASALS AS WELL AS THE BOLUS WIZARD. 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 | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |