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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-941T MIO 2PK 6MM 18IN BLUE SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MMT-941T MIO 2PK 6MM 18IN BLUE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-941T
Device Problems Bent (1059); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 03/28/2018
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
Customer's mother reported via phone call that they experienced a high blood glucose level of 600 mg/dl. Customer's mother reported removing their infusion set and finding that the infusion set cannula was bent. Customer believes that the high blood glucose level was due to the bent infusion set cannula. Customer's mother reported that the elevated blood glucose level was treated with a manual injection of insulin. Customer's mother was unable to troubleshoot the bent infusion set cannula during the call as her son was at school. Customer's mother also reported receiving a no delivery alarm at which time the customer's blood glucose level was 400 mg/dl. Customer declined troubleshooting for the high blood glucose level as they believed it was attributable to the bent infusion set cannula. The infusion set is expected to be returned.
 
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Brand NameINFST MMT-941T MIO 2PK 6MM 18IN BLUE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer (Section G)
MEDTRONIC MINIMED
18000 devonshire st.
northridge CA 91325 1219
Manufacturer Contact
gerwin de graaff
18000 devonshire st.
northridge, CA 91325-1219
MDR Report Key7440346
MDR Text Key105834097
Report Number2032227-2018-02619
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 Manufacturer
Source Type consumer
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-941T
Device Catalogue NumberMMT-941T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 04/18/2018 Patient Sequence Number: 1
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