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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 Problem Image Display Error/Artifact (1304)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on [pa date testing completed] with the following findings: during investigation, the pump was powered on and the display was found to be dim and discolored.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.(b)(6).
 
Event Description
The pump was returned for investigation.Investigation revealed a dim and discolored display.This report is made based on results of investigation completed on 06-nov-2019.There was no indication that the product caused or contributed to an adverse event.
 
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Brand Name
ANIMAS VIBE
Type of Device
INSULIN 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 Key9295526
MDR Text Key172812664
Report Number2531779-2019-06036
Device Sequence Number1
Product Code OYC
Combination Product (y/n)Y
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
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 Manufacturer11/06/2019
Was the Report Sent to FDA? Yes
Device Age36 MO
Date Manufacturer Received11/06/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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