FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 3ML
MDR report key: 2930630
·
Received January 28, 2013
Report
- Report Number
- 3004209178-2013-90590
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Date of Event
- July 4, 2012
- Report Date
- January 15, 2013
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K032005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK
- 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.MFG. REPORT 2 OF 2, MEDWATCH REPORT # 3004209178-2013-90590.MFG. REPORT 1 OF 2, MEDWATCH REPORT # 3004209178-2013-90589.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CUSTOMER HAD MULTIPLE ISSUES REGARDING AIR BUBBLES WHEN SHE WAS CHANGING THE INFUSION SET. THE MOTHER STATED THAT THE CUSTOMER WAS HOSPITALIZED TWICE DUE TO HIGH BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37693 | RESERVOIR 3ML | RESERVOIR | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-332A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR |