FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4223411
·
Received November 4, 2014
Report
- Report Number
- 2032227-2014-46805
- Event Type
- Malfunction
- Date Received
- November 4, 2014
- Date of Event
- September 21, 2014
- Report Date
- October 5, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- Reporter Occupation
- OTHER
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).
Additional Manufacturer Narrative · 1
THIS INFORMATION IS PROVIDED IN RESPONSE TO YOUR REQUEST DATED DECEMBER 11, 2014 FOR ADDITIONAL INFORMATION. OUR ORIGINAL MEDWATCH REPORT WAS SUBMITTED WITH THE INCORRECT EVENT TYPE SELECTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP RECEIVED A MISSED BOLUS REMINDER. IT WAS ALSO REPORTED THAT THE HISTORY FILE DID NOT REFLECT THE BOLUSES RECEIVED. CUSTOMER'S BLOOD GLUCOSE READING WAS 199 MG/DL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707324 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |