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 CORPORATION 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 CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP Back to Search Results
Medical Device Problem Code Inaccurate Delivery (2339)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas at the time of this report.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
 
Event or Problem Description
On (b)(6) 2016, a reporter contacted animas alleging that there was an inaccurate delivery issue.This complaint is being reported because the reported issue was not resolved through troubleshooting.There was no allegation of an adverse event associated with this complaint.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ANIMAS VIBE
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
MDR Report Key6032572
Report Number2531779-2016-28664
Device Sequence Number13516719
Product Code LZG
UDI-Device Identifier10840406100570
UDI-Public0110840406100570
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P130007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 09/30/2016
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
Operator of Device Lay User/Patient
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Device Age6 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2016
Initial Report FDA Received Date10/16/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age5 YR
-
-