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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP

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ANIMAS CORPORATION ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problems Partial Blockage (1065); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 21-sep-2018 with the following findings: during investigation, the black box and pump history for the day of the event were overwritten. There were no occlusion alarms observed in the available pump history. The rewind, load cartridge, and prime steps were performed successfully with no alarms. The pump was detecting the correct force. The pump exercised for 12 hours with no occlusions occurring. The pump¿s cover was removed, no intermittent condition was found to the force sensor circuit.
 
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, alleging a occlusion (frequent/persistent) issue. The reporter was not able to provide further information during the initial complaint. Customer technical support made attempts to contact the reporter for additional information and troubleshooting, without success. There was no indication that the product caused or contributed to an adverse event. This is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
 
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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 Key6043578
MDR Text Key122869257
Report Number2531779-2016-29221
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 09/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Device Age0 MO
Event Location No Information
Date Manufacturer Received09/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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