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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
Device Problem Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas for evaluation. An evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a temperature (temp - no physical damage) issue. This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission 02/01/2017 device evaluation: the device has been returned and evaluated by product analysis on 01/24/2017 with the following findings: a review of the black box showed no evidence of unusual voltage fluctuations. The battery compartment and cap were undamaged and were able to fit securely. The rewind, load, and prime steps were performed successfully. All currents read within specifications. No overheating occurred during the investigation. The pump cover was removed to find no intermittent conditions to the printed circuit board or the continuous glucose monitoring module. The complaint of a temperature issue was unable to be duplicated.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer (Section G)
ANIMAS CORPORATION
200 lawrence dr
west chester PA 19380 3428
Manufacturer Contact
karin sargrad
200 lawrence dr
west chester, PA 19380-3428
4843561808
MDR Report Key6130873
MDR Text Key61207877
Report Number2531779-2016-32305
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 11/01/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received11/01/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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