FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3022019
·
Received March 26, 2013
Report
- Report Number
- 2032227-2013-01160
- Event Type
- Malfunction
- Date Received
- March 26, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 22, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP GAVE AN ALARM DURING THE BASIC OCCLUSION TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD A MISSING END CAP STICKER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP GAVE AN ALARM AND SQUIRTED OUT INSULIN DURING THE MANUAL PRIME. IT WAS ALSO STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDING FROM THE CASE. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 123351 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-723LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |