• 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
Device Problems Moisture Damage (1405); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 08/30/2017 with the following findings: during investigation, the battery compartment was found to be cracked at the threads to the left side of the grip pad and from the case seal to the bumper. Moisture was observed in the battery compartment. A leak test was performed and a leak was identified in the battery compartment and at the bottom right corner between the keypad and pump seal. Unrelated to the original complaint, moisture was identified through the display lens. The pump cover was opened and moisture was found throughout the pump casing.
 
Manufacturer Narrative
The pump has been returned to animas for evaluation. An evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2017, the reporter contacted animas, alleging a casing/condition (case damage w/moisture)- battery compartment and moisture issue. There was no indication the product caused or contributed to an adverse event. This complaint is being reported because the alleged malfunction can result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key6746067
MDR Text Key107133410
Report Number2531779-2017-16052
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 07/02/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/02/2017
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 Unkown

-
-