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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MM T-925T MIO 2PK 6MM 32IN PINK SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MM T-925T MIO 2PK 6MM 32IN PINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-925T
Device Problems Bent (1059); Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 09/25/2017
Event Type  Injury  
Manufacturer Narrative
Note: this is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on october 1, 2017. Subsequently, medtronic diabetes conducted a two year retrospective review of complaints. This event was retrospectively identified to be reportable based on the revised mdr reportability criteria. 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 reported via phone call that they were hospitalized with a high blood glucose. Blood glucose level was 600 mg/dl. The customer reported that they received a no delivery alarm. Customer reports having change the infusion set and reservoir several times. Customer reports that they are able to troubleshoot. Customer reports that insulin exited the at the quick release during troubleshooting. Customer reports that the infusion set cannula was bent upon removal. Customer reports that the cannula occurred during insertion. Customer was advised to change the infusion set again. The product is expected to be returned.
 
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Brand NameINFST MM T-925T MIO 2PK 6MM 32IN PINK
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 Key6988689
MDR Text Key90605318
Report Number2032227-2017-62829
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 10/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/01/2020
Device Model NumberMMT-925T
Device Catalogue NumberMMT-925T
Device Lot Number5176171
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 Received09/26/2017
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: 10/30/2017 Patient Sequence Number: 1
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