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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 been returned to animas but 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 prime (loss of prime) issue. There was no indication that the product caused or contributed to an adverse event. This is reportable as 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 09/21/2016 device evaluation: the device has been returned and evaluated by product analysis on 08/29/2016 with the following findings: there was no evidence of a 162 warning observed in the black box. The rewind, load cartridge and prime steps were successfully performed with no alarms. The force sensor was found to be within calibration. The pump was exercised for 24 hours with no loss of prime warnings. The reported issue was not duplicated during testing. (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 Key5882120
MDR Text Key52298765
Report Number2531779-2016-21444
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
Type of Report Initial,Followup
Report Date 07/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2016
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 Manufacturer08/12/2016
Was the Report Sent to FDA? Yes
Device Age9 MO
Event Location No Information
Date Manufacturer Received07/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2015
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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