FDA Adverse Event
Death
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 3088175
·
Received May 1, 2013
Report
- Report Number
- 3004209178-2013-92889
- Event Type
- Death
- Date Received
- May 1, 2013
- Date of Event
- October 2, 2010
- Report Date
- April 8, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OYC
- PMA / PMN Number
- P980022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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.
Description of Event or Problem · 1
CUSTOMER'S SPOUSE CALLED TO REPORT DEATH. CUSTOMER HAD CANCER FOR FIVE YEARS AND WAS TAKING VARIOUS MEDICATIONS, WHICH WAS CAUSING HIS KIDNEYS TO SHUT DOWN. CAUSE OF DEATH WAS CARDIO INFARCTION, DIABETES MELLITUS AND MULTIPLE MYELOMA. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190295 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-722NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death |