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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 Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas. 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 power (intermittent power) 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 04/26/2016. Device evaluation: the pump has been returned and evaluated by product analysis on 04/14/2016 with the following findings: a review of the black box data showed multiple unexplained reboots on 03/14/2016. A visual inspection of the pump showed that the battery compartment was cracked. No battery cap was returned with the pump; a test cap was able to fully secure on to the pump to maintain an electrical connection. The pump successfully passed the ez prime steps. The pump was exercised for 24 hours with no power interruptions or alarms. The pump cover was opened and moisture corrosion was found to the printed circuit board and continuous glucose monitoring module.
 
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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 Key5528980
MDR Text Key41476730
Report Number2531779-2016-06642
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 03/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610005121846211816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age12 MO
Event Location No Information
Date Manufacturer Received03/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2015
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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