FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3081738
·
Received April 29, 2013
Report
- Report Number
- 3004209178-2013-92853
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- March 25, 2013
- Report Date
- April 4, 2013
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREADS. DRIVE SUPPORT DISK WAS INSPECTED AND NO ANOMALY WAS NOTED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE INSULIN PUMP HAS A MISSING DRIVE SUPPORT CAP. THE INSULIN PUMP HAS A CRACK ON THE BATTERY COMPARTMENT. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183866 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MMT-523NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |