• 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 Displays Incorrect Message (2591)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Urinary Frequency (2275); Polydipsia (2604)
Event Date 06/15/2016
Event Type  Injury  
Manufacturer Narrative
The product 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 alleging a blood glucose of 29 mmol/l with symptoms of tiredness, extreme thirst and urination related to frequent persistent occlusion alarms on the pump. Troubleshooting of the event found that the infusion set and cartridges were used per the instructions for use and supplies had been changed since the issue first started. The reporter indicated that the pump's sensitivity was set to high and the delivery speed was set to normal. This report is made based on the allegation that the patient experienced hyperglycemia related to frequent occlusion alarms on the insulin pump.
 
Manufacturer Narrative
Follow-up #1 date of submission 09/08/2016-product analysis: the device was returned and evaluated by product analysis on 08/12/2016 with the following findings: the complaint could not be duplicated or confirmed with investigation. Review of the pump¿s black box revealed occlusion alarms occurring after the alert date. Data relevant to the alleged event was overwritten due to continued pump use. The total daily dose history and basal history were appropriate for the programmed delivery settings. The pump successfully completed a prime sequence, bolus deliveries, and 24-hour exercise test without issue or alarm. The force sensor calibration was found to be within specification. The pump passed a delivery accuracy test. 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. (b)(4).
 
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 Key5759262
MDR Text Key48456043
Report Number2531779-2016-13960
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
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 06/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age5 MO
Event Location No Information
Date Manufacturer Received06/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/13/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/29/2016 Patient Sequence Number: 1
-
-