FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2771081
·
Received October 3, 2012
Report
- Report Number
- 3004209178-2012-89868
- Event Type
- Malfunction
- Date Received
- October 3, 2012
- Date of Event
- February 6, 2012
- Report Date
- September 26, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGZ
- PMA / PMN Number
- K031390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED AN ERROR DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. UNABLE TO CONFIRM THE MOTOR ERROR ALARM.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE DEVICE ALARMED AN ERROR DURING THE PRIME PROCESS. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM INSULIN INFUSION PUMP | LZG | LGZ | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-712WWB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |