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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-874T SURETPRDGM 2PK 8MM23N 21L SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MMT-874T SURETPRDGM 2PK 8MM23N 21L SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-874T
Device Problem Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 02/18/2016
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 has been having bent infusion set cannulas. Customer's blood glucose level at the time of the incident was 600 mg/dl. Customer was able to perform troubleshooting for the bent cannula during the call. No troubleshooting was performed for the elevated blood glucose. No product is expected to be returned.
 
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Brand NameINFST MMT-874T SURETPRDGM 2PK 8MM23N 21L
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 Key7175241
MDR Text Key96744460
Report Number2032227-2018-00498
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 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-874T
Device Catalogue NumberMMT-874T
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 Received03/11/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
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