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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); Temperature Problem (3022)
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 temperature (temp - moisture ingress w/ dmg) issue. It was reported that there was damage to the battery compartment. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no indication that the product caused or contributed to an adverse event.
 
Manufacturer Narrative
Follow-up #1: date of submission: 08/25/2016. Device evaluation: the device has been returned and evaluated by product analysis on 08/02/2016 with the following findings: a review of the pump¿s black box revealed no activity related to the pi observed in the black box or download history. No overheating was duplicated during testing. The pump¿s electrical current draws were found to be within specification. The battery compartment was found to be cracked below the bumper pad. There was corrosion observed in the battery compartment. A leak test was performed and failed due to a crack in the pump case. The pump was opened and there was no further 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 Key5791569
MDR Text Key50122294
Report Number2531779-2016-16009
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 06/24/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610005121345861016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age17 MO
Event Location No Information
Date Manufacturer Received06/24/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2015
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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