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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 Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a audio tone/vibration (intermittent sound) 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 04/22/2016 - device evaluation: the pump has been returned and evaluated by product analysis on 04/07/2016 with the following findings: during investigation, the pump powered on with no auditory sounds upon start up. The pump¿s cover was removed and the piezo spring contacts were found to be misaligned; after a realignment of the piezo spring contacts, the auditory feature functioned properly. The complaint of a ¿chirp alarm¿ was not duplicated during investigation.
 
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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 Key5546342
MDR Text Key42071453
Report Number2531779-2016-07162
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 03/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610007521790465416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age1 MO
Event Location No Information
Date Manufacturer Received03/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2016
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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