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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED SILHOUETTE INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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MEDTRONIC MINIMED MINIMED SILHOUETTE INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number MMT-383A
Device Problems Failure to Deliver (2338); Material Twisted/Bent (2981)
Patient Problem Hyperglycemia (1905)
Event Date 05/27/2022
Event Type  Injury  
Event Description
Medtronic silhouette infusion sets from lot 5350768 have repeated occurrences of failure starting from (b)(6) 2022 and again on (b)(6) 2022.Manufacturer has not offered to replace remaining medical devices associated with this manufacturing lot.Product issue is due to kinking of the infusion set tubing, leading to insulin not being delivered to the patient and resulting in severe hyperglycemia events that require emergent response using an alternate means of insulin delivery, such as a syringe.Fda safety report id # (b)(4).
 
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Brand Name
MINIMED SILHOUETTE INFUSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key14575408
MDR Text Key293312927
Report NumberMW5110035
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/27/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/01/2024
Device Catalogue NumberMMT-383A
Device Lot Number5350768
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Treatment
BAYER CONTOUR NEXT LINK GLUCOMETER; DEXCOM G6 CGM SYSTEM USED FOR BLOOD GLUCOSE MONITORING; HUMALOG INSULIN DELIVERED VIA ; MEDTRONIC 770G INSULIN PUMP
Patient Outcome(s) Life Threatening;
Patient Age34 YR
Patient SexMale
Patient Weight91 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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