• 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 Problem Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to animas. 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 Description
On (b)(6) 2016, the reporter contacted animas and alleged that the pump had temperature issues. There was no damage to the pump. There was no allegation of an adverse event. This complaint is reported because of the potential for the user to experience an injury to the skin due to increased pump temperature.
 
Manufacturer Narrative
Follow-up #1 date of submission 01/06/2017-correction to initial reporter name: (b)(6).
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 2/13/2017 with the following findings: a review of the pump¿s black box and download history did not find any unusual voltage fluctuations. The battery compartment and battery cap were intact and the battery cap could be fully tightened onto the pump. The pump powered on normally with no overheating or alarms duplicated during the investigation. The pump¿s ¿ez-prime¿ steps were performed correctly and all of the pump's electrical current draws were found to be within specification. The pump cover was removed and there were no intermittent condition found to the printed circuit board (pcb) or to the continuous glucose monitoring (cgm). The investigation was unable to duplicate the initial ¿temperature¿ complaint. Unrelated to the initial complaint, it was observed that the cartridge compartment was missing a fragment around the threads contour but the returned cartridge cap was still able to fit onto the cartridge compartment. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
 
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 Key6220117
MDR Text Key63951543
Report Number2531779-2017-00098
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,Followup
Report Date 12/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age11 MO
Event Location No Information
Date Manufacturer Received12/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/29/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-