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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-923T MIO 2PK 6MM 23IN PINK SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MMT-923T MIO 2PK 6MM 23IN PINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-923T
Device Problem Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 06/25/2016
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. 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 they received a high blood glucose level of 439 mg/dl. Customer reported also having issues with no delivery alarms and had found that the infusion set cannulas were bent at the time of these incidents. Customer treated the high blood glucose level with a manual injection of insulin using a syringe. Customer was able to troubleshoot the bent infusion set cannula. Customer declined troubleshooting for the high blood glucose and no delivery alarms, as she believed that were due to the bent infusion set cannula. No product is expected to be returned.
 
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Brand NameINFST MMT-923T MIO 2PK 6MM 23IN 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 Key7175664
MDR Text Key96752735
Report Number2032227-2018-00511
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 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 Expiration Date01/31/2019
Device Model NumberMMT-923T
Device Catalogue NumberMMT-923T
Device Lot Number5135141
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 Received06/27/2016
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: 01/09/2018 Patient Sequence Number: 1
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