• 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-905T MIO 2PK 13MM23N 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-905T MIO 2PK 13MM23N SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-905T
Device Problems Bent (1059); Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem Irritation (1941)
Event Date 03/04/2017
Event Type  malfunction  
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. 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 9. 1 mmol/l. Customer was able to troubleshoot at the time of the call. The infusion set cannula was bent upon removal. Customer reported red irritation, blood and pain at the infusion set insertion site. The infusion set is not expected to be returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINFST MMT-905T MIO 2PK 13MM23N
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 Key7251889
MDR Text Key99800698
Report Number2032227-2018-01344
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Patient
Type of Report Initial
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2019
Device Model NumberMMT-905T
Device Catalogue NumberMMT-905T
Device Lot Number5136899
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 Received03/04/2017
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

-
-