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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MM T-975T MIO 2PK 9MM 32IN CLEAR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-975T
Device Problem Kinked (1339)
Patient Problem Hypoglycemia (1912)
Event Date 01/20/2018
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. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
Customer reported via phone call that she experienced a low blood glucose level of 42 mg/dl. Customer treated the low blood glucose with a manual injection of glucagon. Customer was able to troubleshoot during the call. Customer reported that the infusion set tubing had a kink in it. No product is expected to be returned.
 
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Brand NameINFST MM T-975T MIO 2PK 9MM 32IN CLEAR
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 Key7218571
MDR Text Key98209988
Report Number2032227-2018-00987
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
Type of Report Initial
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-975T
Device Catalogue NumberMMT-975T
Device Lot Number5184083
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 Received01/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/25/2018 Patient Sequence Number: 1
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