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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 08-jul-2019 with the following findings: during investigation, the complaint regarding prime issue was reported on (b)(6)2016 , according to the pump history the pump was in used until (b)(6) of 2019. Therefore all data from time of complaint has been overwritten. The available black box and pump history show no evidence of prime or delivery defects. 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 pump 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, the reporter contacted animas alleging a prime (prime issue) issue. There is no indication that the product issue 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 Key6051924
MDR Text Key189563240
Report Number2531779-2016-29550
Device Sequence Number1
Product Code MDS
UDI-Device Identifier10840406100051
UDI-Public011084040610005121365861216
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 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2016
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? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Device Age20 MO
Event Location No Information
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/22/2015
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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