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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 Image Display Error/Artifact (1304); Moisture Damage (1405); Failure to Read Input Signal (1581)
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 09-jan-2020 the following findings: during investigation, the keypad is intact with no evidence of peeling or damage.Additionally, the display was found to be dim/faded.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/fading color spectrum.This report is made based on results of investigation completed on 09-jan-2020.
 
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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 Key9584477
MDR Text Key179252935
Report Number2531779-2020-00014
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 01/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
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 Manufacturer01/08/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
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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