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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); Failure to Read Input Signal (1581)
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.
 
Event Description
On (b)(6) 2018, the reporter contacted animas, alleging a button/keypad (tactile changes with moisture) issue. The reporter alleged the up arrow, down arrow, contrast, and ok buttons were under responsive. Allegedly, there was moisture behind the display. There was no indication that the product caused or contributed to an adverse event. The complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 06-jun-2018 with the following findings: during investigation, the pump failed to power on. No damage was found to the keypad. The keypad was removed to find no damage to the button contacts. Moisture was found in the display. Unrelated to the original complaint, the battery compartment was cracked alongside of the pump. The pump leaked at the battery compartment. The pump was opened and moisture damage was found on the printed circuit board. There was no power to the pump due to moisture damage.
 
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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 Key7563602
MDR Text Key110353647
Report Number2531779-2018-10197
Device Sequence Number1
Product Code MDS
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
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 Manufacturer06/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received05/24/2018
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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