FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3171131
·
Received June 14, 2013
Report
- Report Number
- 2032227-2013-02448
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- April 27, 2013
- Report Date
- April 29, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH CONSTANT VIBRATION AND A FROZEN SCREEN DUE TO MOISTURE DAMAGE ON THE ELECTRONICS. MOISTURE DAMAGE WAS ALSO FOUND ON THE MOTOR. NO CONSTANT ALARM TONE WAS NOTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED MOISTURE INSIDE THE CASING OF THE INSULIN PUMP. THE CUSTOMER STATED THAT HE WENT ON VACATION, AND WENT INTO A POOL, BUT REMOVED THE INSULIN PUMP. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270950 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523LNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |