FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4153748
·
Received October 8, 2014
Report
- Report Number
- 2032227-2014-35304
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 9, 2014
- Report Date
- September 9, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- 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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Additional Manufacturer Narrative · 1
INSULIN PUMP RECEIVED WITH NO BUTTON RESPONDING PROPERLY. SLIGHTLY MOISTURE DAMAGE WAS FOUND AT KEYPAD TRACES. INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNERS.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE ESC BUTTON ON THE INSULIN PUMP IS NOT RESPONDING. CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING TO THE KEYPAD ISSUE. BLOOD GLUCOSE VALUE IS UNKNOWN. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631863 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723LNAB | A1723LNABJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |