FDA Adverse Event
Malfunction
Summary report: N
530G INSULIN PUMP
MDR report key: 4111110
·
Received September 23, 2014
Report
- Report Number
- 2032227-2014-23039
- Event Type
- Malfunction
- Date Received
- September 23, 2014
- Date of Event
- July 21, 2014
- Report Date
- July 22, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- OZO
- PMA / PMN Number
- 120010
- 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'S BLOOD GLUCOSE SUDDENLY HAS BEEN DROPPING IN THE MIDDLE OF THE NIGHT. THE CUSTOMER STATED HAVING THREE TO FOUR INFUSION SETS AND RESERVOIRS LET. THE CALLER ALSO STATED THAT THE SENSOR ALARMS WERE ALSO ANNOYING. THE CUSTOMER BELIEVES THAT THE CHANGES ON HER SCHEDULE WERE AFFECTING HER GLUCOSE LEVEL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591716 | 530G INSULIN PUMP | OZO | OZO | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-751NAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |