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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
Device Problem Structural Problem (2506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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. (b)(6).
 
Event Description
On (b)(6) 2018, the reporter contacted animas, alleging a casing/condition (cracked/damaged casing) issue. It was alleged that the battery compartment was damaged. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 24-oct-2018 with the following findings: during investigation, the battery compartment was found to be cracked.
 
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Brand NameANIMAS VIBE
Type of DeviceINSULIN INFUSION PUMP
Manufacturer (Section D)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer (Section G)
ANIMAS LLC
965 chesterbrook blvd
wayne PA 19087
Manufacturer Contact
kristen lopolito
965 chesterbrook blvd
wayne, PA 19087
MDR Report Key7987717
MDR Text Key124983622
Report Number2531779-2018-18516
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2018
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 Manufacturer10/22/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/09/2018
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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