FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4192649
·
Received October 22, 2014
Report
- Report Number
- 2032227-2014-41112
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- June 22, 2014
- Report Date
- September 22, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH NO ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO STICKY BUTTONS WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND A CRACKED RESERVOIR TUBE LIP.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THEY HAVE TO PRESS HARD TO GET THE ACT BUTTON TO RESPOND. CUSTOMER STATED THAT WHEN THEY BOLUS IT TAKES A WHILE BEFORE THERE IS A RESPONSE. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672542 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |