• 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 INPEN

  • 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 INPEN Back to Search Results
Model Number MMT-XXX
Device Problem Obstruction of Flow (2423)
Patient Problem Insufficient Information (4580)
Event Date 08/06/2019
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. This mdr is related to the retrospective review of complaints from companion medical inc, following medtronic¿s acquisition of the company in september 2020.
 
Event Description
The customer reported via phone call that they were having issues with insulin delivery on their insulin pen. Customer¿s blood glucose was unknown. No harm requiring medical intervention was reported. The insulin pen will not be returned for analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINPEN
Type of DeviceINPEN
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
tricha miles
18000 devonshire st.
northridge, CA 91325-1219
7635140379
MDR Report Key11880790
MDR Text Key255510104
Report Number2032227-2021-149010
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2019
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

-
-