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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED PARADIGM QUICK SET MMT-399T SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-399T
Device Problem Bent (1059)
Patient Problem Hyperglycemia (1905)
Event Date 08/07/2016
Event Type  Injury  
Manufacturer Narrative
Note: 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 experienced a high blood glucose level of 400 mg/dl. Customer reported that they believed the high blood glucose level was due to a bent infusion set cannula preventing the proper delivery of insulin. Customer reported that they had experienced a bent infusion set cannula. Customer was able to troubleshoot for the bent infusion set cannula. Customer did not troubleshoot for the elevated blood glucose level. No product is expected to be returned.
 
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Brand NamePARADIGM QUICK SET MMT-399T
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 Key7175376
MDR Text Key96746771
Report Number2032227-2018-00502
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 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 Model NumberMMT-399T
Device Catalogue NumberMMT-399T
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 Received08/09/2016
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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