FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3771745
·
Received April 24, 2014
Report
- Report Number
- 3004209178-2014-83955
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- February 19, 2014
- Report Date
- April 17, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE DEVICE WAS RECEIVED WITH SCRATCHED SCREEN, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249658 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |