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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 Temperature Problem (3022)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas for evaluation.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 temperature (temp - no physical damage) issue.There was no indication that the product caused or contributed to an adverse event.This issue is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.
 
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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 Key6860788
Report Number2531779-2017-21023
Device Sequence Number13675636
Product Code OYC
UDI-Device Identifier10840406100037
UDI-Public0110840406100037
Combination Product (Y/N)N
Initial Reporter StateTX
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 Patient
Type of Report Initial
Report Date (Section B) 08/18/2017
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
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/18/2017
Initial Report FDA Received Date09/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age22 YR
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