FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2870023
·
Received December 12, 2012
Report
- Report Number
- 2032227-2012-08026
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- August 9, 2012
- Report Date
- November 30, 2012
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP ALARM MOTOR ERROR DURING THE BASIC OCCLUSION TEST, DUE TO LOOSE DRIVE SUPPORT DISK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP HAD INSULIN SQUIRTING OUT AND ALARMING DURING MANUAL PRIME. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM INSULIN INFUSION PUMP | LZG | LZG | MEDTRONIC MINIMED | MMT-515NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |