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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 Problems Partial Blockage (1065); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 07-nov-2018 with the following findings: a review of the pump¿s black box showed evidence of multiple occlusion alarms associated with high force. During testing, the pump successfully completed the rewind, load, and prime steps without any call service alarms, warnings or issues. The force sensor calibration was found to be within required specification. No occlusions occurred during testing. The original complaint of an occlusion issue was noted in the pump history but unable to be duplicated during investigation. 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.
 
Manufacturer Narrative
The device has not been returned to animas. 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, it was reported that the pump experienced at least one occlusion alarms. There is no indication that the pump caused or contributed to an adverse event. This complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.
 
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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 Key6026487
MDR Text Key127205486
Report Number2531779-2016-28407
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/23/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2016
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 Manufacturer10/31/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Device Age4 MO
Event Location No Information
Date Manufacturer Received09/23/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2016
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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