FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522NAB PRDGM INS V2.2 BL EN
MDR report key: 1950976
·
Received January 3, 2011
Report
- Report Number
- 3004209178-2010-83711
- Event Type
- Malfunction
- Date Received
- January 3, 2011
- Date of Event
- December 10, 2010
- Report Date
- December 10, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AS A RESULT OF MOISTURE DAMAGE ON THE FORCE SENSOR. FURTHER TESTING WAS NOT PERFORMED DUE TO THE MOTOR ERROR ALARM.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR TWICE IN THE PAST COUPLE DAYS. THE CUSTOMER STATED THAT THE DEVICE WAS NOT EXPOSED TO A MAGNETIC FIELD. PERFORMED A DISPLACEMENT TEST AND THE INSULIN PUMP DID NOT PASS THE TEST. ADVISED THE CUSTOMER TO REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-522NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |