FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4241814
·
Received November 10, 2014
Report
- Report Number
- 2032227-2014-50105
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- March 13, 2011
- Report Date
- October 13, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL REGISTERED PROPERLY IN THE BOLUS HISTORY NOTED. NO HISTORY ANOMALY NOTED. THE DEVICE WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT HER BOLUSES ARE NOT REGISTERING HER BOLUS HISTORY. THE BLOOD GLUCOSE READING IS UNKNOWN. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723833 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |