FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522CAS PRDGM INS V2.2 SK EN PR
MDR report key: 1810938
·
Received August 9, 2010
Report
- Report Number
- 3004209178-2010-82401
- Event Type
- Malfunction
- Date Received
- August 9, 2010
- Date of Event
- July 8, 2010
- Report Date
- July 30, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AS A RESULT OF MOISTURE DAMAGE FOUND ON THE ELECTRONIC ASSEMBLY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED. THE DEVICE RESTED AND THE BATTERY WAS CHANGED, BUT THE INSULIN PUMP WAS UNRESPONSIVE. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522CAS PRDGM INS V2.2 SK EN PR | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522CAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |