FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3981970
·
Received August 5, 2014
Report
- Report Number
- 2032227-2014-05438
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. INSULIN PUMP WAS UNABLE TO PERFORM DISPLACEMENT TEST DUE TO MOTOR ERROR ALARM. INSULIN PUMP HAD MINOR SCRATCHES ON DISPLAY WINDOW AND CRACKED DISPLAY WINDOW CORNER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A MOTOR ERROR ALARM ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 261 MG/DL. THE CUSTOMER STATED THAT THERE WAS NO SIGNIFICANT EVENT THAT COULD HAVE LED TO THE MOTOR ERROR ALARM. THE CUSTOMERS INSULIN PUMP WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 458049 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-723RNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |