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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 Device Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
On (b)(6) 2016, the reporter contacted animas alleging that the pump has malfunctioned multiple times with error codes. There was no allegation of an adverse event with this complaint. Customer support has made several attempts to contact the reporter in follow up, however, the reporter did not respond. No further information was available; if further information is provided a follow up report shall be mad. This complaint is being reported based on the allegation of a non-specific pump malfunction.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 05/19/2017 with the following findings: review of the black box revealed records of call service alarms (088, 054, 052). The pump powered on normally for investigation. The pump was successfully primed and exercised for 24 hours without call service alarms occurring. The pump was opened for further investigation and did not reveal any evidence of damage, defect or contamination of the pump¿s internal components. The alleged call service alarms were confirmed in the pump history, but not duplicate during investigation. The pump performed as intended without malfunction. (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 Key6269127
MDR Text Key65779435
Report Number2531779-2017-01859
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 12/27/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2017
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 Manufacturer05/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age19 MO
Event Location No Information
Date Manufacturer Received12/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2015
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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