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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 Problems Device Displays Incorrect Message (2591); Connection Problem (2900)
Patient Problem Hyperglycemia (1905)
Event Date 03/24/2018
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 that they received a no delivery alarm. Customer's blood glucose level at the time of the incident was 523 mg/dl. Customer was able to troubleshoot. Customer was able to troubleshoot during the pump during the call. Customer's no delivery alarm was caused by an infusion set/reservoir connection. The pump 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 Key7370459
MDR Text Key103460928
Report Number2032227-2018-02186
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 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-975T
Device Catalogue NumberMMT-975T
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 Received03/24/2018
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: 03/26/2018 Patient Sequence Number: 1
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