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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 Failure to Prime (1492)
Patient Problem No Consequences Or Impact To Patient (2199)
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 that the pump repeatedly emitted loss of prime warnings despite cartridge changes. There was no indication that the product caused or contributed to an adverse event. This complaint 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.
 
Manufacturer Narrative
Follow-up #1: date of submission 03/15/2017. Device evaluation: the device has been returned and evaluated by product analysis on 02/25/2017 with the following findings: on review of the black box data multiple loss of prime warnings were recorded associated with a non-primed pump. On testing, the pump was powered on and rewind, load and prime sequence was successfully performed without alarm. Force calibration testing was performed and within specifications. The pump was exercised for 24 hours without duplication of loss of prime. Investigation did not duplicate the complaint. (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 Key6262248
MDR Text Key65510674
Report Number2531779-2017-01504
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 distributor,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 12/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2017
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age4 MO
Event Location No Information
Date Manufacturer Received12/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/10/2016
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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