FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3083625
·
Received April 29, 2013
Report
- Report Number
- 3004209178-2013-92884
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 5, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH A SCRATCHED DISPLAY WINDOW AND A PROTRUDED/LOOSE DRIVE SUPPORT DISK.
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT IS REPORTED CUSTOMER RESPONDED TO THE FIELD NOTIFICATION LETTER, REGARDING THE DRIVE SUPPORT CAP. DRIVE SUPPORT CAP IS PROTRUDING. CUSTOMER PUSHED THE CAP IN. CUSTOMER ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. CUSTOMER AGREED TO RETURN THE INSULIN PUMP. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185302 | 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 | 29 YR |