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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 Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (external component issue) issue. It was reported that the battery cap had stripped threads. There is no indication that the product issue 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 cap.
 
Manufacturer Narrative
Follow-up #1: date of submission 08/22/2016. Device evaluation: the device has been returned and evaluated by product analysis on 08/02/2016 with the following findings: during investigation, the battery cap was found to be damaged. The threads were noted to have been stripped and torn. The battery cap was difficult to attach and did not fully tighten to the test pump. The yellow o-ring was visible. Unrelated to the original complaint, there was visible rust on the battery cap.
 
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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 Key5815720
MDR Text Key50963598
Report Number2531779-2016-17186
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 07/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2016
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 Manufacturer07/22/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received07/02/2016
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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