FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3801225
·
Received May 8, 2014
Report
- Report Number
- 3004209178-2014-84483
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- April 6, 2014
- Report Date
- April 29, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH AN INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. NO STICKING KEYPAD NOTED. THE DEVICE WAS RECEIVED WITH SCRATCHED SCREEN, CRACKED RESERVOIR TUBE LIP, LOOSE DRIVE SUPPORT DISK, AND MISSING END CAP STICKER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE KEYPAD WAS STICKY. THE CALLER STATED THAT THE NUMBERS DID NOT APPEAR ON THE SCREEN WHILE PRESSING THE ACTIVATE BUTTON. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278593 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |