FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722WWS PRDGM INSULIN SK EN ML
MDR report key: 1900061
·
Received November 8, 2010
Report
- Report Number
- 3004209178-2010-83277
- Event Type
- Malfunction
- Date Received
- November 8, 2010
- Date of Event
- October 27, 2010
- Report Date
- November 2, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH A FROZEN SCREEN AFTER COUNT UP DUE TO A PROBLEM WITH THE LIQUID CRYSTAL DISPLAY BOARD. UNABLE TO PERFORM FURTHER TESTING DUE TO THE FROZEN SCREEN.
Description of Event or Problem · 1
THE INSULIN PUMP WAS RETURNED FOR AN UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722WWS PRDGM INSULIN SK EN ML | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722WWS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |