FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-712LWWB PRDGM INS BL EN LN
MDR report key: 1732570
·
Received June 14, 2010
Report
- Report Number
- 2032227-2010-81452
- Event Type
- Malfunction
- Date Received
- June 14, 2010
- Date of Event
- July 7, 2009
- Report Date
- July 13, 2009
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LGZ
- PMA / PMN Number
- K031390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. THE INSULIN PUMP HAD MOISTURE DAMAGE ON THE MOTOR.
Description of Event or Problem · 1
IT WAS STATED THAT THE SCREEN WENT BLANK AFTER THE INSULIN PUMP WAS SUBMERGED IN WATER. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-712LWWB PRDGM INS BL EN LN | INFUSION PUMP | LGZ | MEDTRONIC MINIMED | MMT-712LWWB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |