FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 4213572
·
Received October 13, 2014
Report
- Report Number
- 2032227-2014-37214
- Event Type
- Malfunction
- Date Received
- October 13, 2014
- Date of Event
- September 13, 2014
- Report Date
- September 13, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).
Description of Event or Problem · 1
IT IS REPORTED THAT CUSTOMER RECEIVED A MOTOR ERROR ALARM. INSULIN PUMP WILL BE REPLACED. NO FURTHER INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647410 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722CAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |