FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3082724
·
Received April 29, 2013
Report
- Report Number
- 3004209178-2013-92945
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 8, 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
PRIME ALARM DURING BASIC OCCLUSION TEST DUE PROTRUDED/LOOSE DRIVE SUPPORT DISK.
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE AND HER INSULIN PUMP IS ALARMING AND SQUIRTING THE INSULIN OUT DURING THE MANUAL PRIME. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS PROTRUDING OUT ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185467 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-523NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR |