FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 4170949
·
Received October 14, 2014
Report
- Report Number
- 2032227-2014-38064
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 15, 2014
- Report Date
- September 15, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND ALARM COULD NOT BE CLEARED. CUSTOMER CHANGED THE BATTERY BUT THE ALARM RECURS. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 649617 | PARADIGM INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-515WWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |