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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
The pump has been returned and evaluated by product analysis on 14-jan-2020 with the following findings: the battery compartment was found to be cracked.(b)(6).
 
Event or Problem Description
The pump was returned for investigation.Investigation revealed casing/condition (cracked/damaged casing) issue.This report is made based on results of investigation completed on 14-jan-2020.There was no indication that the product caused or contributed to an adverse event.
 
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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 Key9602193
Report Number2531779-2020-00020
Device Sequence Number2669180
Product Code OYC
UDI-Device Identifier10840406103199
UDI-Public10840406103199
Combination Product (Y/N)Y
Initial Reporter StateOK
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) 01/14/2020
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 Manufacturer01/10/2020
Was the Report Sent to FDA? Yes
Device Age23 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/14/2020
Initial Report FDA Received Date01/17/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age46 YR
Patient Weight130
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