FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2791871
·
Received October 15, 2012
Report
- Report Number
- 3004209178-2012-90083
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- August 6, 2012
- Report Date
- October 1, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST, AND THE DEVICE ALARMED DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. HOWEVER, THE DEVICE PASSED THE DISPLACEMENT TEST, AND THE MOTOR PASSED THE TEST. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP ALARMED AN ERROR DURING THE PRIME PROCESS. THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | OYC | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |