FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4200558
·
Received October 24, 2014
Report
- Report Number
- 2032227-2014-42724
- Event Type
- Malfunction
- Date Received
- October 24, 2014
- Date of Event
- September 24, 2014
- Report Date
- September 24, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAS RECEIVED UNEXPLAINED NO DELIVERY ALARMS AND HAS HAD TO RESTART THE REWIND TO COMPLETE. IT WAS ALSO STATED THAT CUSTOMER HAD TO FREQUENTLY CHANGE THE BATTERY AND THE ACT BUTTON ON THE INSULIN PUMP STICKS. CUSTOMER DECLINED TO TROUBLESHOOT. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 679138 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-722LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR |