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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 Failure to Read Input Signal (1581)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to animas.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
 
Event or Problem Description
On (b)(6) 2017, the reporter contacted animas, alleging a button/keypad (tactile changes/unresponsive) issue.The reporter alleged that the ok/enter button's were under responsive on the keypad.There was no indication that the product caused or contributed to an adverse event.The complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.
 
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Brand Name
ANIMAS VIBE
Common Device Name
INSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
200 lawrence dr
west chester PA 19380 3428
MDR Report Key7698530
Report Number2531779-2018-13062
Device Sequence Number13678994
Product Code OYC
UDI-Device Identifier10840406100228
UDI-Public10840406100228
Combination Product (Y/N)Y
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P130007
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other Caregivers
Type of Report Initial
Report Date (Section B) 06/28/2018
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? No
Was the Report Sent to FDA? Yes
Device Age23 MO
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/28/2018
Initial Report FDA Received Date07/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age71 YR
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