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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 Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 10/26/2016
Event Type  Injury  
Manufacturer Narrative
This is a remediation mdr. Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 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 no delivery alarm that was resolved by changing their infusion set. The customer's blood glucose level at the time of the incident was 505 mg/dl. Customer treated the elevated blood glucose level with a bolus from her insulin pump. Customer was not able to troubleshoot at the time of the call. The infusion set is not 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 Key7234594
MDR Text Key98831946
Report Number2032227-2018-01150
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 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2017
Device Model NumberMMT-923T
Device Catalogue NumberMMT-923T
Device Lot Number002980877T
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 Received10/26/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/19/2016
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: 02/01/2018 Patient Sequence Number: 1
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