FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3100521
·
Received May 8, 2013
Report
- Report Number
- 3004209178-2013-93219
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Date of Event
- April 5, 2013
- Report Date
- April 12, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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 WAS RECEIVED WITH PROTRUDED/LOOSE DRIVE SUPPORT DISK, CRACKED BLEEDING AND SCRATCHED DISPLAY WINDOW. UNIT WAS ALSO RECEIVED WITH VIBRATOR RATTLING DUE TO VIBRATOR ADHESIVE WAS NOT ADHERING.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE INSULIN PUMP DRIVE SUPPORT CAP IS STICKING OUT. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200274 | 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 | 53 YR |