FDA Adverse Event
Malfunction
Summary report: N
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
MDR report key: 1931909
·
Received December 10, 2010
Report
- Report Number
- 3004209178-2010-83580
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- FRN
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
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.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT INSULIN WAS LEAKING FROM THE RESERVOIR WHILE FILLING. THE CUSTOMER STATED THAT THE LEAKS WERE PAST THE O-RINGS. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSVR MMT-326A 10PK PRDGM 1.8ML 13L | DISPOSABLE | FRN | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-326A | H7463048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |