• 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 Crack (1135); Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 07/15/2016 with the following findings: the battery compartment was found to be cracked at the threads. There was corrosion found in the battery compartment. The pump failed a leak test as a result of the battery compartment crack. (b)(6).
 
Event Description
The pump was returned for investigation. Investigation revealed that the battery compartment was cracked and moisture was present. This report is made based on results of investigation completed on (b)(6) 2016.
 
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 Key5848969
MDR Text Key52545248
Report Number2531779-2016-18999
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 company representative
Reporter Occupation Patient
Type of Report Initial
Report Date 07/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610008221965415316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age16 MO
Event Location No Information
Date Manufacturer Received07/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-