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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 Problems Bent (1059); Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/03/2017
Event Type  malfunction  
Manufacturer Narrative
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 that they observed broken infusion set needles on 4 infusion sets. Customer reported that the infusion set fracture was observed when removing products from original packaging. Customer reports that needles were bent a 90-degree angle. Customer also reported experiencing difficulty removing the top from the casing. Troubleshooting was performed. Customer's blood glucose was 84 mg/dl at time of call. Product is not 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 Key6985688
MDR Text Key90797631
Report Number2032227-2017-62575
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 10/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received10/03/2017
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

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