FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 1.8 ML
MDR report key: 2800668
·
Received October 22, 2012
Report
- Report Number
- 3004209178-2012-90247
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Date of Event
- September 5, 2012
- Report Date
- October 11, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- FRN
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
INSPECTED ONE OPENED AND USED RESERVOIR. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER SPECIFICATIONS. NO LEAKAGE ANOMALY WAS OBSERVED DURING ANALYSIS. CHECKED O-RINGS FOR DEFECTS AND NONE WERE FOUND.
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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT INSULIN FROM THE RESERVOIR WAS LEAKING PAST THE O-RINGS INTO THE RESERVOIR COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESERVOIR 1.8 ML | FRN | FRN | MEDTRONIC PUERTO RICO OPERATIONS CO. | MMT-326A | H8081655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |