FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3120958
·
Received May 20, 2013
Report
- Report Number
- 3004209178-2013-93790
- Event Type
- Malfunction
- Date Received
- May 20, 2013
- Date of Event
- April 28, 2013
- Report Date
- April 28, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST AND PRIME ALARM DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM OCCLUSION TEST DUE TO MOTOR ERROR ALARM. ALL THE BUTTONS FUNCTIONED PROPERLY AND NO BUTTON ERROR ALARM OR MOISTURE DAMAGE ON KEYPAD TRACES NOTED. THE INSULIN PUMP HAD A SCRATCHED LCD WINDOW. NO ALARM OR CHANGE SENSOR ALARM NOTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE READING IS 251 MG/DL. CUSTOMER HAS TREATED WITH A BOLUS. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS PROTRUDED. ADVISED CUSTOMER THAT THE INSULIN PUMP MUST BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221844 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-723NAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |