FDA Adverse Event
Death
Summary report: N
530G INSULIN PUMP
MDR report key: 4210358
·
Received October 25, 2014
Report
- Report Number
- 2032227-2014-37975
- Event Type
- Death
- Date Received
- October 25, 2014
- Date of Event
- July 1, 2014
- Report Date
- October 23, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- OZO
- PMA / PMN Number
- 120010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).
Description of Event or Problem · 1
NO BLOOD GLUCOSE LEVELS REPORTED. IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY SOMETIME IN (B)(6) 2014. NO EXACT DATES WERE PROVIDED. THE EMPLOYER OF THE CUSTOMER REPORTED THE CUSTOMER'S DEMISE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680647 | 530G INSULIN PUMP | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO | MMT-751NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death |