• 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 Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has not been returned to animas for evaluation. 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, alleging a power (intermittent power) issue. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow up #1 submitted 3/07/2016: a review of the complaint record indicated this complaint was received by animas on 2/25/16, not 2/26/16 as previously reported.
 
Manufacturer Narrative
Device evaluation: the device was returned to animas and evaluated by product analysis on 04/04/2016 with the following results: issue confirmed in history but not duplicated in testing. Pump was exercised with returned battery cap for 24 hours with no reboot, loss of power or call service alarms duplicated. A "intermittent power or cs 052" event was not duplicated during investigation. Black box dates from (b)(6) 2016. Bb data from date of complaint has been overwritten. Current bb shows no evidence of an "intermittent power" event however cs 052/054 errors observed in alarm history 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 Key5471509
MDR Text Key39581791
Report Number2531779-2016-05011
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 02/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610009921476836416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age7 MO
Event Location No Information
Date Manufacturer Received02/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/07/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-