FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 1.8 ML
MDR report key: 2061347
·
Received March 17, 2011
Report
- Report Number
- 2032227-2011-00690
- Event Type
- Malfunction
- Date Received
- March 17, 2011
- Date of Event
- February 26, 2011
- Report Date
- March 5, 2011
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FRN
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED HAVING TROUBLE WITH INSULIN LEAKING FROM MULTIPLE RESERVOIRS. ADVISED THAT THE RESERVOIRS WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESERVOIR 1.8 ML | RESERVOIR | FRN | MEDTRONIC MINIMED | MMT-326A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |