FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4192745
·
Received October 22, 2014
Report
- Report Number
- 2032227-2014-41569
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 9, 2014
- Report Date
- September 23, 2014
- Manufacturer
- MEDTRONIC MINIMED
- 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. 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 A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, A CRACKED DISPLAY WINDOW, AND MINOR SCRATCHES ON THE DISPLAY WINDOW.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP HAS A CRACK ON THE SCREEN. CUSTOMER DOES NOT NOW HOW THE DAMAGE OCCURRED. CUSTOMER STATED THAT THE CRACK IS ON THE UPPER LEFT HAND CORNER ON THE SCREEN NEAR THE RESERVOIR. BLOOD GLUCOSE VALUE IS UNKNOWN. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671223 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |