FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4232947
·
Received November 6, 2014
Report
- Report Number
- 2032227-2014-48597
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- July 8, 2014
- Report Date
- October 11, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE ON THE LCD DISPLAY WINDOW AND LCD WINDOW CORNERS, AS WELL AS CRACKS ON THE BATTERY TUBE THREAD AND THE RESERVOIR TUBE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE CRACKS NEAR THE BATTERY COMPARTMENT OF THE CUSTOMER'S INSULIN PUMP. THE CUSTOMER DECLINED TO VOLUNTEER BLOOD GLUCOSE LEVEL. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714621 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |