FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4150297
·
Received October 7, 2014
Report
- Report Number
- 2032227-2014-34299
- Event Type
- Malfunction
- Date Received
- October 7, 2014
- Date of Event
- November 4, 2013
- Report Date
- November 4, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).THE INSULIN PUMP WAS RECEIVED WITH A MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOMES WITCH. THE DEVICE WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP. THE DEVICE WAS RECEIVED WITH CRACKED BELT CLIP SLOT.THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
IT WAS REPORTED THE CUSTOMER RECEIVED A MOTOR ERROR ALARM. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 629171 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-754WWH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |