FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4111132
·
Received September 23, 2014
Report
- Report Number
- 2032227-2014-23014
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- June 20, 2014
- Report Date
- June 20, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP RECEIVED WITH CRACKED CASE DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP. (B)(4).
Description of Event or Problem · 1
CUSTOMER CALLED TO REPORT THE INSULIN PUMP HAD A CRACK AROUND THE OPENING OF THE RESERVOIR COMPARTMENT. RESERVOIR DID NOT LOCK INTO PLACE PROPERLY DUE TO THE DAMAGE. CUSTOMER STATED THE DAMAGE OCCURRED FROM NORMAL USE. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592048 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |