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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 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.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.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a prime (unable to prime) 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 04/19/2016-product analysis: the device was returned and evaluated by product analysis on 04/13/2016 with the following findings: the complaint could not be duplicated with investigation.Review of the pump¿s black box revealed multiple loss of prime warnings.The pump successfully completed a prime sequence, bolus deliveries, and 24-hour exercise test without issue or alarm.The pump¿s force sensor was found to be within specification.
 
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Brand Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key5485114
MDR Text Key40033076
Report Number2531779-2016-05373
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age3 MO
Initial Date Manufacturer Received 03/02/2016
Initial Date FDA Received03/07/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age20 YR
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