Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE; INSULIN INFUSION PUMP
  • 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
 

ANIMAS LLC ANIMAS VIBE; INSULIN INFUSION PUMP Back to Search Results
Device Problems Image Display Error/Artifact (1304); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 26-dec-2018 with the following findings: evaluation revealed a crack in the battery compartment and a dim, discolored display.(b)(6).
 
Event Description
The pump was returned for investigation.Evaluation revealed a crack in the battery compartment and a dim, discolored display.There was no adverse event associated with this complaint.This report is made based on results of investigation completed on 26-dec-2018.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANIMAS VIBE
Type of Device
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer (Section G)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer Contact
kristen lopolito
965 chesterbrook blvd
wayne, PA 19087
MDR Report Key8207302
MDR Text Key131771375
Report Number2531779-2018-21018
Device Sequence Number1
Product Code OYC
Combination Product (y/n)Y
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 12/26/2018
Initial Date FDA Received12/31/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-