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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 Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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) 2016, the reporter contacted animas, alleging a power (intermittent power) issue. There was no additional information available for this complaint. 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 06/10/2016. Device evaluation: the device has been returned and evaluated by product analysis on 05/23/2016 with the following findings: a review of the black box revealed unexplained "power on reset" events on 03/08/2016 and 03/11/2016. The battery compartment was found to be intact. The battery cap width and height measurements were within specifications. The battery cap tightly secured to the pump. The pump was powered on with the returned battery cap. The pump was exercised with the returned battery cap for 24 hours with no reboot, loss of power or call service alarms duplicated. The pump case was removed; there was no evidence of moisture or loose components found inside the pump. The "intermittent power" complaint was not duplicated during investigation. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
 
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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 Key5551869
MDR Text Key42498294
Report Number2531779-2016-07278
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 distributor,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 03/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2016
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 Manufacturer05/09/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age5 MO
Event Location No Information
Date Manufacturer Received03/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2015
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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