FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL
MDR report key: 1993400
·
Received January 21, 2011
Report
- Report Number
- 2032227-2011-00178
- Event Type
- Malfunction
- Date Received
- January 21, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 5, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FROZEN SCREEN AND UNRESPONSIVE BUTTONS. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES WERE NOT RESOLVED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAL | INSULIN INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |