FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
MDR report key: 3112511
·
Received May 14, 2013
Report
- Report Number
- 2032227-2013-01937
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 29, 2013
- Report Date
- April 29, 2013
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A LOOSE/FLUSH MOTOR SUPPORT DISK. MOISTURE DAMAGE WAS NOTED AT THE MOTOR ASSEMBLY. THE INSULIN PUMP HAD MISSING SEGMENTS DUE TO A CRACKED ZEBRA CONNECTOR AT THE LCD BOARD. THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED LCD WINDOW AND MISSING END CAP STICKER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED AN ALARM DURING THE MANUAL PRIME. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212909 | PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-723LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |