FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3980981
·
Received August 5, 2014
Report
- Report Number
- 3004209178-2014-89989
- Event Type
- Malfunction
- Date Received
- August 5, 2014
- Date of Event
- May 25, 2014
- Report Date
- May 25, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE AND BUTTON ERROR ALARM DUE TO CORRODED KEYPAD TRACES. NO MOISTURE DAMAGE FOUND ON ELECTRONIC ASSEMBLY OR MOTOR. DEVICE HAD SCRATCHED LCD WINDOW, BROKEN BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND BROKEN RESERVOIR TUBE LIP.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED A BUTTON ERROR ALARM. CUSTOMER STATED HE IS A LIFE GUARD AND DEVICE WAS EXPOSED TO MOISTURE. BLOOD GLUCOSE LEVEL 123 MG/DL. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457255 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |