FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3203479
·
Received July 2, 2013
Report
- Report Number
- 2032227-2013-02714
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 6, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND ALARMED MOTOR ERROR DURING THE REWIND DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL.
Description of Event or Problem · 1
THE CUSTOMER CALLED TO REPORT A MOTOR ERROR ALARM DURING NORMAL USE. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO AN MRI SCAN ON (B)(6) 2013. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP WAS NOT DAMAGED. THE INSULIN PUMP FAILED THE DISPLACEMENT TEST, AND ALARMED MOTOR ERROR AGAIN. 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 |
|---|---|---|---|---|---|---|---|
| 302311 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722RNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |