FDA.reportPublic FDA data

MAUDE MDR 9720592

MDR report key
9720592
Report number
MW5093017
Event key
0
Event type
3
Date of event
2020-02-08
Date received
2020-02-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDTRONIC 670G INSULIN PUMPAUTOMATED INSULIN DOSING DEVICE SYSTEMMEDTRONIC MINIMEDOZP670GI N
2SIL-SERTERINTRODUCER, SYRINGE NEEDLEMEDTRNIC MINIMEDKZHI *
3SILHOUETTE SETSET, ADMINISTRATION, INTRAVASCULARMEDTRONIC MINIMEDFPAI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-1401. O

Event Narratives#

D

Patient 1

I PREPARED TO CHANGE MY INFUSION SET SITE FOR MY MINIMED 670G PUMP. I USED THE SILHOUETTE INFUSION SETS AND THE "SIL-SERTER" - THE INSERTER THAT ACCOMPANIES THOSE SETS. AFTER I LOADED A NEW SET INTO THE INSERTER AND WENT TO REMOVE THE NEEDLE FROM THE NEW CANNULA, I COULD NOT DISLODGE THE NEEDLE FROM THE CANNULA AT THE NEW SITE. THE NEEDLE, FROM I UNDERSTAND, IS USED TO INSERT THE CANNULA UNDER THE SKIN AND ONCE REMOVED ALLOWS FOR THE INSULIN RESERVOIR TO BE ATTACHED OR REMOVED BASED UPON ACTIVITY OR PREFERENCE ETC. BECAUSE I WAS UNABLE TO REMOVE THE NEEDLE FROM THE NEW SITE AND CANNULA, I HAD TO COMPLETELY REMOVE THE NEW INFUSION SET AND DISCARD IT. THIS LED TO EXTREME DISCOMFORT AND BLEEDING. I ALSO AM NOT SURE WHY THE NEEDLE WOULD NOT DISLODGE FROM THE NEW SET / CANNULA AREA AFTER INSERTION. FDA SAFETY REPORT ID# (B)(4).