FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4223088
·
Received November 4, 2014
Report
- Report Number
- 2032227-2014-47416
- Event Type
- Malfunction
- Date Received
- November 4, 2014
- Date of Event
- July 16, 2014
- Report Date
- July 16, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP RECEIVED WITH EXTREMELY SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE LIP, MISSING END CAP STICKER.
Description of Event or Problem · 1
IT WAS REPORTED ON (B)(6) 2014, THE DISPLAY ON THE INSULIN PUMP WAS SCRATCHED. CUSTOMER STATED IT WAS NOT POSSIBLE TO READ ALL OF THE INFORMATION PROPERLY. CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705566 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722LWWS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |