FDA Adverse Event
Malfunction
Summary report: N
INSULIN INFUSION PUMP
MDR report key: 4190490
·
Received October 21, 2014
Report
- Report Number
- 2032227-2014-41065
- Event Type
- Malfunction
- Date Received
- October 21, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 22, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- 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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SHE WAS HAVING PROBLEMS WITH INFUSION SETS. CUSTOMER STATED THAT DOCTOR STATED THAT SHE NEEDS TO CHANGE INFUSION SETS BECAUSE IT WAS LEAKING. CUSTOMER THINKS IT WAS THE INSULIN PUMP THAT WAS LEAKING AND CUSTOMER DOES NOT KNOW WHAT SET TO GO. CALL GOT DISCONNECTED. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666943 | INSULIN INFUSION PUMP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |