• 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 OTHER SENSOR, GLUCOSE, INVASIVE

  • 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 OTHER SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number MMT-XXX
Device Problems Crack (1135); No Display/Image (1183); Device Displays Incorrect Message (2591); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2017
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
The customer reported via phone call the insulin pump had a button error alarm and a blank display issue. The customer¿s blood glucose was unknown at the time of incident. Customer stated that the insulin pump kept turning off and would not deliver insulin. Customer stated that the insulin pump alarmed button error and the buttons works intermittently. No significant events leading to keypad anomaly were observed. Keypad anomaly troubleshooting was performed and confirmed that time is advancing. Customer also reported cracks on the insulin pump battery and reservoir compartment due to normal wear and tear. The customer was advised to discontinue use of pump and revert to back-up plan. The insulin pump is being replaced and is not expected to return for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOTHER
Type of DeviceSENSOR, GLUCOSE, INVASIVE
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 Key6813995
MDR Text Key83498105
Report Number2032227-2017-39718
Device Sequence Number1
Product Code MDS
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 08/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-XXX
Device Catalogue NumberMMT-XXX
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 Received08/02/2017
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

-
-