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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE INSULIN INFUSION PUMP

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ANIMAS LLC ANIMAS VIBE INSULIN INFUSION PUMP Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
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) 2018, the reporter contacted animas, alleging a call service alarm (cs 064) issue. There was no indication that the product 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 LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer (Section G)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer Contact
kristen lopolito
965 chesterbrook blvd
wayne, PA 19087
MDR Report Key8158472
MDR Text Key130175785
Report Number2531779-2018-20586
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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