Model Number MMT-751NAS |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/06/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Currently it is unknown whether or not the device may have caused or contributed to the event.The device has been returned, but not yet evaluated.Further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
|
|
Event Description
|
A customer reported via phone call indicating drive support cap on their insulin pump was flush.The customer¿s blood glucose level was 160 mg/dl at the time of the incident.The customer was informed that the insulin pump needed to be replaced and was advised to discontinue use of the insulin pump and to revert to the back up plan.The customer sent the product back for analysis.
|
|
Manufacturer Narrative
|
(b)(4).A complete analysis and testing of the insulin pump showed that it was functioning properly and passed all functional testing.After testing it was concluded that the device operated within specifications.
|
|
Search Alerts/Recalls
|