FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3112643
·
Received May 14, 2013
Report
- Report Number
- 3004209178-2013-93444
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 9, 2013
- Report Date
- April 29, 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 DAMAGE BATTERY CAP COIN SLOT, CRACKED RESERVOIR TUBE LIP, UNIT FAILED DISPLACEMENT TEST WITH UNITS LEFT ON STATUS SCREEN, AND MOTOR ERROR ALARM DURING REWIND DUE TO OUT OF PHASE MOTOR ENCODER SIGNAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING NORMAL USED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212701 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |