FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3982313
·
Received August 5, 2014
Report
- Report Number
- 2032227-2014-06188
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 3, 2014
- Report Date
- July 3, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH UNRESPONSIVE BUTTONS DUE TO FLATTENED DOME SWITCH. NO BLANK DISPLAY WAS NOTED. THE DEVICE ALSO HAD A SCRATCHED LCD WINDOW, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS AND A BLANK DISPLAY. THE BLOOD GLUCOSE READING WAS 100 MG/DL. TROUBLESHOOTING WAS NOT PERFORMED BECAUSE THE DEVICE HAD ALREADY BEEN RETURNED FOR ANALYSIS; CUSTOMER CALLED TO CONFIRM THE DEVICE'S ARRIVAL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457097 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-723RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |