FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 2191280
·
Received July 28, 2011
Report
- Report Number
- 2032227-2011-01842
- Event Type
- Malfunction
- Date Received
- July 28, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 1, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A FROZEN DISPLAY ON THE INSULIN PUMP. THE CALLER WAS A NURSE, BUT SHE DIDN'T HAVE FURTHER INFO. ATTEMPTED TO CONTACT THE CUSTOMER MULTIPLE TIMES, BUT GOT NO ANSWER. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-723RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR |