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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 Poor Quality Image (1408)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a display (dim/fading/color spectrum) 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 09/16/2016. Device evaluation: the device has been returned and evaluated by product analysis on 08/26/2016 with the following findings: during investigation, the pump powered on to a dim and discolored display. Unrelated to the original complaint, the audio bolus button cover was torn; however, the bolus button was responsive during the investigation. In addition, the battery compartment was cracked. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release. (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 Key5828281
MDR Text Key51821614
Report Number2531779-2016-17681
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 07/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2016
Was the Report Sent to FDA? Yes
Device Age27 MO
Event Location No Information
Date Manufacturer Received07/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2014
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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