FDA Adverse Event
Malfunction
Summary report: N
RSVR MMT-326A 10PK PRDGM 1.8ML 13L
MDR report key: 1062773
·
Received June 16, 2008
Report
- Report Number
- 2032227-2008-00987
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Date of Event
- May 27, 2008
- Report Date
- March 21, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FMF
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INSPECTED ONE OPENED/USED RESERVOIR AND IT FAILED PER SPECIFICATIONS. THE RESERVOIR LEAKED PAST THE FIRST AND SECOND O-RINGS DUE TO PLUNGER DAMAGE WITH SEVERAL INDENTATIONS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED CONTINUOUS PROBLEMS WITH AIR BUBBLES IN THE RESERVOIRS. THE CUSTOMER SPOKE WITH HER DIABETES EDUCATOR ABOUT THE ISSUE, BUT THE PROBLEMS CONTINUE. THE CUSTOMER WAS GIVEN SUGGESTIONS ON HOW TO PREVENT AIR BUBBLES. THE CUSTOMER WILL RETURN A RESERVOIR FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSVR MMT-326A 10PK PRDGM 1.8ML 13L | DISPOSABLES | FMF | MEDTRONIC MINIMED | MMT-326A | WA2507144 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |