FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4141932
·
Received October 4, 2014
Report
- Report Number
- 2032227-2014-33045
- Event Type
- Malfunction
- Date Received
- October 4, 2014
- Date of Event
- September 5, 2014
- Report Date
- September 5, 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
- 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 HAD INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGE ON THE KEYPAD TRACES. NO NUMBER RAMPING ANOMALY WAS NOTED ON THE DISPLAY. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT, A CRACKED RESERVOIR TUBE LIP AND A CRACKED RESERVOIR TUBE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT WHEN SHE ENTERS A BOLUS THE NUMBERS KEEP SCROLLING. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621522 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |