FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2800730
·
Received October 22, 2012
Report
- Report Number
- 2032227-2012-07496
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Date of Event
- August 13, 2012
- Report Date
- October 17, 2012
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED AN ERROR DURING THE BASIC OCCLUSION TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD SCRATCHED DISPLAY WINDOW.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED AN ERROR DURING THE MANUAL PRIME. THE CALLER STATED THAT ALARM OCCURRED WITH MULTIPLE INFUSION SETS. INSTRUCTED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. 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 MINIMED | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |