• 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 Electrical /Electronic Property Problem (1198); Moisture Damage (1405); Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (damage with moisture ingress) issue. It was reported that the battery compartment was cracked/damaged with moisture ingress and that the pump experienced no power. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 15-jun-2018 with the following findings: a review of the pump black box showed one pump reboot after a replace battery alarm. A visual inspection of the pump revealed multiple cracks in the battery compartment. Corrosion was observed inside the battery compartment. The returned battery cap had stripped threads and was unable to maintain electrical connection, duplicating the reported power issue. A test battery cap was able to fit to maintain electrical connection and was used to complete a 24 hour duration test; no reboots or power loss was duplicated during investigation. A leak test indicated a battery compartment leak. The pump cover was removed; no further evidence of moisture was observed on the printed circuit board or other internal components. No damage to the power circuit was found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS LLC
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key7604172
MDR Text Key112046460
Report Number2531779-2018-10946
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 06/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
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 Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received06/03/2018
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 Unkown

-
-