FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4183171
·
Received October 17, 2014
Report
- Report Number
- 2032227-2014-40068
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Date of Event
- September 18, 2014
- Report Date
- September 19, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- PATIENT
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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).
Description of Event or Problem · 1
NO BLOOD GLUCOSE LEVELS WERE PROVIDED. THE CUSTOMER REPORTED UNEXPLAINED NO DELIVERY ALERTS FROM THE INSULIN PUMP. THE CUSTOMER ALSO REPORTED NEEDING TO CHANGE THE BATTERY OF THE INSULIN PUMP FREQUENTLY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 660299 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-523LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |