FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2984080
·
Received February 28, 2013
Report
- Report Number
- 3004209178-2013-91491
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- September 13, 2012
- Report Date
- February 22, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD A CRACKED DISPLAY WINDOWL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AND INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, BUT THE CUSTOMER WAS DISCONNECTED DURING PRIME. IT WAS STATED THAT THE PISTON CONTINUES MOVING FORWARD AFTER THE RESERVOIR MAKES CONTACT AND INSULIN SQUIRTS OUT, FOLLOWED BY THE ALARM. IT WAS MENTIONED THAT THE NUMBERS DID NOT APPEAR ON THE SCREEN, AND THE BEEPS COULD NOT BE HEARD. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86459 | PARADIGM INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-712WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |