FDA Adverse Event
Injury
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 6073585
·
Received November 2, 2016
Report
- Report Number
- 2032227-2016-39441
- Event Type
- Injury
- Date Received
- November 2, 2016
- Date of Event
- September 30, 2016
- Report Date
- October 4, 2016
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME
- Reporter Occupation
- PATIENT
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
CUSTOMER REPORTED VIA PHONE CALL TO HAVE RECEIVED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. CUSTOMER WAS ABLE TO RESOLVE NO DELIVERY WITH A COMPLETE SET CHANGE. CUSTOMER WOULD SEND PRODUCT FOR FAILURE ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725097 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-522NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |