FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3112612
·
Received May 14, 2013
Report
- Report Number
- 3004209178-2013-93487
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 21, 2013
- Report Date
- April 21, 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 PRIME ALARM DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP HAD A MISSING END CAP STICKER.
Description of Event or Problem · 1
IT WAS REPORTED BY CUSTOMER'S MOTHER, THAT THE DRIVE SUPPORT CAP IS PROTRUDED AND THE INSULIN PUMP ALARMED PRIME ALARM. CUSTOMER'S BLOOD GLUCOSE READING IS 199 MG/DL. THE INSULIN PUMP HAS COSMETIC DAMAGE. THE DRIVE SUPPORT CAP HAS BEEN PROTRUDED FOR AWHILE. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212205 | 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 | 17 YR |