FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 4203826
·
Received October 27, 2014
Report
- Report Number
- 2032227-2014-43760
- Event Type
- Malfunction
- Date Received
- October 27, 2014
- Date of Event
- September 30, 2014
- Report Date
- September 30, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE. UNIT HAD MOISTURE DAMAGE ON ELECTRONICS.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT WHEN SHE GOT OUT OF THE SHOWER SHE NOTICED MOISTURE IN THE INSULIN PUMP AND ALSO NOTICED THREE CRACKS AROUND THE SCREEN AND ON CORNERS. MOISTURE WAS ALSO VISIBLE UNDER THE BATTERY CHAMBER. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 112 MG/DL. NO FURTHER INFORMATION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683663 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-523LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |