FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3974385
·
Received August 1, 2014
Report
- Report Number
- 3004209178-2014-89102
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- January 28, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP RECEIVED WITH NORMAL OPERATING CURRENTS. NO UNEXPECTED WEAK BATTERY ALARM NOTED. DEVICE RECEIVED WITH CRACKED DISPLAY WINDOW CORNER, RESERVOIR TUBE LIP, SCRATCHED LCD WINDOW.
Description of Event or Problem · 1
CUSTOMER COMPLAINED ABOUT THE INSULIN PUMP ALARMING WEAK BATTERY. CUSTOMER STATED THAT THE BATTERY LIFE HAS BEEN SHORTENED. CUSTOMER STATED THAT HE CHANGED TWO TIMES IN 10 DAYS. CUSTOMER USING THE RECOMMENDED BATTERY TYPE. BLOOD GLUCOSE 118 MG/DL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 450530 | 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 | 56 YR |