FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 3191760
·
Received June 26, 2013
Report
- Report Number
- 3004209178-2013-95078
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- April 4, 2013
- Report Date
- June 12, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LZG
- PMA / PMN Number
- K040676
- 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 DETACHED END CAP. THE DEVICE DID NOT AUTOMATICALLY STOP DURING OUR TEST.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP AUTOMATICALLY STOPPED FUNCTIONING. THE ALARM HISTORY WAS REVIEWED AND FOUND AN ERROR ALARM. ADVISED THAT THE DEVICE WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290237 | PARADIGM INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-715WWB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |