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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 Inaccurate Delivery (2339)
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.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a history settings (inaccurate delivery) issue. There was no indication that the device caused or contributed to an adverse event. This complaint is being reported based on the allegation against the delivery function of the pump.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 03/22/2017 with the following findings: the black box begins on (b)(6) 2017. Due to continuous use of the pump the black box data/histories for the event have been overwritten. Available daily insulin delivery totals correctly reflect the users programmed basal rates. The pump passed delivery accuracy test and was found to be delivering within required range and delivering accurately. Unable to duplicate the complaint, the pump information for the complaint date has been overwritten. 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.
 
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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 Key6106043
MDR Text Key60363575
Report Number2531779-2016-31455
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 10/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2016
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 Manufacturer03/16/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age12 MO
Event Location No Information
Date Manufacturer Received10/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2015
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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