• 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 Problems Failure to Prime (1492); Inaccurate Delivery (2339); High Test Results (2457)
Patient Problems Abdominal Pain (1685); Dehydration (1807); Dyspnea (1816); Fatigue (1849); Hyperglycemia (1905); Polydipsia (2604)
Event Type  Injury  
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 that on an unspecified date, the patient experienced a blood glucose over 500 mg/dl with abdominal pain, extreme drowsiness, polydipsia, symptoms of dehydration, shortness of breath and difficulty waking up associated with an inaccurate delivery issue.Reportedly, the patient remained on the insulin pump and did not receive any treatment above and beyond the usual routine of diabetes care and management.During troubleshooting with customer technical support, it was revealed that the basal delivery totals in the total daily dose did not match due to a loss of prime and the bolus totals did not match.This complaint is being reported because the patient allegedly experienced hyperglycemia because of an inaccurate delivery issue.
 
Manufacturer Narrative
Follow-up #1: date of submission 04/12/2016.Device evaluation: the device has been returned and evaluated by product analysis on 03/28/2016 with the following findings: the last basal delivery was on 03/09/2016 at 10:25am and the last bolus delivery was on 03/09/20 16 at 09:09am.Both bolus history and total daily dose (tdd) reflected a 24.2u bolus delivery on 02/24/2016.The tdd added up and reflected the programmed bolus and basal target.¿ez-prime¿ steps were performed correctly with no delivery interruption during the investigation.The pump reflected 24u after a 24hr on 1u/hr duration basal test.A 10u normal bolus and 10u audio bolus were delivered correctly and both boluses were recorded at the correct time and order in the bolus history.The tdd reflected 20u bolus total.The product performed within specifications.The original complaint could not be duplicated or confirmed.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 Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key5514144
MDR Text Key40790610
Report Number2531779-2016-06292
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
Report Date 03/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Other Device ID Number011084040610009921399262816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age0 MO
Initial Date Manufacturer Received 03/02/2016
Initial Date FDA Received03/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age22 YR
-
-