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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED INFST MMT-864T SURETPRDGM 2PK 6MM23N 21L SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-864T
Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem Hyperglycemia (1905)
Event Date 10/14/2016
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. 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 had a high blood glucose level of 500 mg/dl. Customer treated the elevated blood glucose level with a manual injection of insulin. The customer was able to troubleshoot during the call. Customer disconnected at the quick release and attempted to perform a fixed prime. Customer reported that insulin did exit the infusion set tubing and the pump did not continue to alarm no delivery. The customer reported that the infusion set cannula was not bent. The product is expected to be returned.
 
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Brand NameINFST MMT-864T SURETPRDGM 2PK 6MM23N 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 Key7237623
MDR Text Key98887858
Report Number2032227-2018-01214
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 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-864T
Device Catalogue NumberMMT-864T
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 Received10/14/2016
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: 02/02/2018 Patient Sequence Number: 1
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