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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. (b)(6).
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a occlusion (occlusion issue) 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
Follow-up #1: date of submission 05/04/2016. Device evaluation: the pump has been returned and evaluated by product analysis on 04/21/2016 with the following findings: a review of the black box data showed several occlusion alarms occurring due to high force. During testing, the pump successfully completed the ez prime steps. The pump was exercised for 24 hours with no loss of prime. The force sensor calibration was found to be within specifications. The complaint was not duplicated during testing. Unrelated to the complaint, the battery compartment was 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.
 
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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 Key5554085
MDR Text Key42620632
Report Number2531779-2016-07299
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age14 MO
Event Location No Information
Date Manufacturer Received03/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2015
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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