• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED INFST MMT-394T QCKSTPRDGM 2PK 6MM18N SET, ADMINISTRATION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MINIMED INFST MMT-394T QCKSTPRDGM 2PK 6MM18N SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-394T
Device Problems Failure To Adhere Or Bond (1031); Bent (1059); Component Falling (1105)
Patient Problem Hyperglycemia (1905)
Event Date 12/09/2016
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. 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's mother reported via phone call that they experienced a high blood glucose level. Customer's mother reported that the customer's blood glucose level was reported as being 400 mg/dl at the time of the incident. Customer's mother reported that her daughter's blood glucose level at the time of the call was 379 mg/dl. Customer's mother reported that she treated her daughter's elevated blood glucose level with a manual injection of insulin. Customer's mother reported that they last changed their infusion set earlier in the day of the call. Customer's mother was able to troubleshoot during the call. Customer's mother also reported an infusion set falling off. Customer's mother declined troubleshooting for the adhering anomaly. Customer's mother reported that the upon removal of the infusion set that was in use during the elevated blood glucose incident, she found that the infusion set cannula was bent like a big curved knitting needle. The infusion set is expected to be returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINFST MMT-394T QCKSTPRDGM 2PK 6MM18N
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 Key7151408
MDR Text Key95938782
Report Number2032227-2017-77751
Device Sequence Number1
Product Code FPA
UDI-Device Identifier20613994761754
UDI-Public(01)20613994761754(017)20170701
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 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/01/2017
Device Model NumberMMT-394T
Device Catalogue NumberMMT-394T
Device Lot Number002979807T
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 Received12/09/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/09/2016
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: 12/28/2017 Patient Sequence Number: 1
-
-