FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3982053
·
Received August 5, 2014
Report
- Report Number
- 3004209178-2014-89810
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- July 4, 2014
- Report Date
- July 4, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
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
FAILURE ANALYSIS REVEALED THE INSULIN PUMP WAS RECEIVED WITH BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. THE UNIT HAD CRACKED DISPLAY WINDOW CORNER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED RECEIVING A BUTTON ERROR ALARM ON THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 238 MG/DL AT THE TIME THE ISSUE WAS REPORTED. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO SWEAT. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457457 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723LNAB | A3723LNABJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |