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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP
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ANIMAS CORPORATION 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 09-dec-2017 with the following findings: during testing, it was observed that the ok button was cracked and under responsive to user presses.(b)(6).
 
Event or Problem Description
The pump was returned for investigation.Investigation revealed a cracked and under responsive ok button.This report is made based on results of investigation completed on 09-dec-2017.
 
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Brand Name
ANIMAS VIBE
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
MDR Report Key7170792
Report Number2531779-2018-00432
Device Sequence Number19089948
Product Code OYC
UDI-Device Identifier10840406100372
UDI-Public10840406100372
Combination Product (Y/N)N
Initial Reporter StateAZ
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 Other Caregivers
Type of Report Initial
Report Date (Section B) 12/09/2017
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
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2017
Was the Report Sent to FDA? Yes
Device Age18 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/09/2017
Initial Report FDA Received Date01/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age11 YR
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