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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 Problem Occlusion Within Device (1423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has not been returned to animas for evaluation. 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. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 06/20/2016 with the following findings: a review of the pump¿s black box revealed occlusion alarms. The force at the time of the occlusions was high. The rewind, load and prime steps were performed successfully with no alarms. The force sensor calibration test confirmed the sensor was detecting the correct force. The pump was exercised for 24 hours with no occlusions occurring. Unrelated to the original complaint, the battery compartment was observed to be cracked. 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).
 
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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 Key5702771
MDR Text Key46875786
Report Number2531779-2016-11154
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 05/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610006821816040716
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age14 MO
Event Location No Information
Date Manufacturer Received05/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2015
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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