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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 Problems Moisture Damage (1405); 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. 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 Description
On (b)(6) 2016, the reporter contacted animas alleging a casing/condition (case damage w/moisture) issue. It was reported that the battery compartment was cracked and there was moisture present in the pump. The alleged issue could not be resolved with troubleshooting. 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 compartment.
 
Manufacturer Narrative
Follow-up # 1: date of submission: 12/25/2016. Device evaluation: the device has been returned and evaluated by product analysis on 12/07/2016 with the following findings: during visual inspection of the pump, it was observed that the battery compartment had two cracks. There was moisture observed inside the battery compartment. A leak test was performed and failed due to the battery compartment crack. The pump was opened and there was no evidence of moisture found.
 
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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 Key6066912
MDR Text Key59043909
Report Number2531779-2016-30114
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 10/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2016
Was the Report Sent to FDA? Yes
Device Age17 MO
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2015
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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