FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS
MDR report key: 1963922
·
Received January 11, 2011
Report
- Report Number
- 3004209178-2011-80123
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 9, 2010
- Report Date
- January 5, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A STRIPPED BATTERY CAP. THE DEVICE ALSO HAD A FROZEN DISPLAY AS A RESULT OF A FAULTY COMPONENT ON THE MOTHERBOARD.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED LOW BATTERY AND THEN THE DEVICE TURNED OFF. THE BATTERY WAS REPLACED AND THE DISPLAY ON THE DEVICE WAS STUCK. 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 | PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS | INSULIN INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |