FDA Adverse Event
Malfunction
Summary report: N
RESERVOIR 1.8ML
MDR report key: 4233451
·
Received November 6, 2014
Report
- Report Number
- 2032227-2014-48741
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- August 30, 2014
- Report Date
- October 9, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- FRN
- PMA / PMN Number
- K001828
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN
- Reporter Occupation
- PATIENT
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.
Additional Manufacturer Narrative · 1
ANALYSIS INSPECTED ONE OPENED AND USED RESERVOIRS PERFORMED PRE-FILL RESERVOIRS TEST PER SPECIFICATIONS. RESERVOIRS FAILED PER INSPECTION FOUND RESERVOIR TRANSFER GUARD NEEDLE OCCLUDED.
Description of Event or Problem · 1
CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THEY COULD NOT GET AIR BUBBLES OUT. THE BLOOD GLUCOSE READING IS UNKNOWN. NOTHING FURTHER REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714064 | RESERVOIR 1.8ML | RESERVOIR | FRN | MEDTRONIC MINIMED | MMT-326A | HG05E1E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |