FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3112660
·
Received May 14, 2013
Report
- Report Number
- 3004209178-2013-93458
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 18, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM EXCESSIVE NO DELIVERY ALARMS TEST DUE TO LOOSE DRIVE SUPPORT DISK. NO BURN WIRE OR OTHER COMPONENTS NOTED. UNIT HAD BROKEN RESERVOIR TUBE LIP AND BATTERY TUBE THREADS.
Description of Event or Problem · 1
CUSTOMER CALLED TO REPORT MULTIPLE NO DELIVERY ALARMS AND SHE STATED THAT LOOKS LIKE A WIRE OR SOMETHING INSIDE OF THE INSULIN PUMP CAUGHT ON FIRE. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212167 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-523NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |