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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
Medical Device Problem Code Structural Problem (2506)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 29-nov-2018 with the following findings: evaluation revealed the cartridge compartment was chipped and cracked.(b)(6).
 
Event or Problem Description
The pump was returned for investigation.Evaluation revealed the cartridge compartment was damaged.There was no adverse event associated with this complaint.This report is made based on results of investigation completed on 29-nov-2018.
 
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Brand Name
ANIMAS VIBE
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
MDR Report Key8587253
Report Number2531779-2019-03023
Device Sequence Number1537195
Product Code OYC
UDI-Device Identifier10840406100372
UDI-Public10840406100372
Combination Product (Y/N)Y
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
P130007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Was the Report Sent to FDA? Yes
Device Age29 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/14/2018
Initial Report FDA Received Date05/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age15 YR
Patient Weight78
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