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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)(4).
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging that the load cartridge step displayed 183 units when the cartridge was completely full. This reportedly occurred with several cartridges. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because an inability to complete the prime steps prior to use could lead to a long term cessation of insulin delivery.
 
Manufacturer Narrative
Follow-up #1: date of submission 02/22/2017. Device evaluation: the device has been returned and evaluated by product analysis on 02/06/2017 with the following findings: a review of the black box indicated multiple loss of prime warnings occurred in association with a non-primed pump. The pump powered on normally and successfully completed rewind, load, and prime steps. The pump was exercised for 24 hours with no issues occurring. The force sensor calibration was found to be within specifications. The pump correctly displayed the number of units remaining during investigation. The complaint could not be confirmed or duplicated on investigation. Unrelated to the original complaint, investigation revealed that the battery compartment was cracked and the display was dim and discolored.
 
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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 Key6226340
MDR Text Key64193229
Report Number2531779-2017-00298
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 12/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2017
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 Manufacturer12/30/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age38 MO
Event Location No Information
Date Manufacturer Received12/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2013
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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