• 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 Inaccurate Delivery (2339)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Manufacturer Narrative
Follow-up #1: date of submission 14-jun-2019. Device evaluation: the device has been returned and evaluated by product analysis on 12-jun-2019 with the following findings: a review of the black box showed the data from the date of the complaint had been overwritten due to continuous use. The available daily insulin delivery totals correctly reflected the programmed basal rates. The pump history showed the pump was delivering the programmed basal rate until deliveries were halted by the user. The pump passed delivery accuracy testing and was found to be delivering within the required specifications. 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. This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.
 
Manufacturer Narrative
The pump 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 the pump had an inaccurate delivery issue, starting on (b)(6) 2016. The patient developed a blood glucose (bg) in the 50mg/dl's for which they were treated in the er and released. The low bg was preceded by a correction bolus given approximately 3 hours prior required. The patient is currently under a bg management plan. This complaint is being reported as the patient required emergency room treatment for a bg related to an alleged inaccurate delivery issue.
 
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 Key5741181
MDR Text Key193453869
Report Number2531779-2016-12712
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
Type of Report Initial,Followup
Report Date 05/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610006821440224616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Device Age2 MO
Event Location No Information
Date Manufacturer Received05/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2016
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: 06/22/2016 Patient Sequence Number: 1
-
-