• 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 Failure to Prime (1492)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
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 on (b)(6) 2016, the patient noticed a load step malfunction: the pump going to the load step but only loading for about 2 seconds even when minimal insulin is in cartridge, ex: 30u. Patient then checks the insulin remaining and it does not correlate with the amount left in the cartridge. The pump shows almost a full amount remaining even when only 30u in cartridge. Patient developed a blood glucose of 400 mg/dl with extreme drowsiness. Patient received unspecified treatment from the endocrinologist. This complaint is being reported as the issue may result in inaccurate delivery and the patient developed hyperglycemia.
 
Manufacturer Narrative
Follow-up #1: date of submission 12/14/2016 device evaluation: the device has been returned and evaluated by product analysis on 11/19/2016 with the following findings: no defect was found. No evidence of a load step malfunction observed in the black box. The black box shows an unexplained por (power on reset on (b)(6) 2016 20:17. Pump was powered back on (b)(6) 2016 06:56 but not primed & no deliveries were made. Pump was powered off at 07:10. Deliveries resumed on (b)(6) 2016 11:10. An unexplained por was observed on (b)(6) 2016 06:40; deliveries never resumed. No debris observed in cartridge compartment. Rewind, load & prime steps completed with no issues. A cartridge with approximately 190 u was inserted and recognized correctly by the piston rod. A 24 hr duration test was successfully completed. The pump is detecting the correct force. The tdd¿s add up correctly and reflect the users programmed basal rates. Pump passed delivery accuracy test and was found to be delivering accurately and within range. Removed pump cover; force sensor pins seated and solder connections intact. No evidence of contamination or cracked force sensor traces. No evidence of internal moisture was found. Unable to duplicate the reported complaint.
 
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 Key6033129
MDR Text Key57606368
Report Number2531779-2016-28722
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 09/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2016
Is this an Adverse Event Report? Yes
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 Manufacturer10/25/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age3 MO
Event Location No Information
Date Manufacturer Received09/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2016
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: 10/17/2016 Patient Sequence Number: 1
-
-