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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); 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. 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. No conclusions can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging that the pump had an intermittent power issue since about a week ago. It was reported that the battery compartment threads were stripped and moisture/corrosion was evident in 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 03/25/2016 - device evaluation: the pump has been returned and evaluated by product analysis on 03/22/2016 with the following findings. 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. On investigation, the alleged power issue was not duplicated in the evaluation but the moisture ingress issue was verified. Review of black box data found processor communication related call service alarms on the complaint date. A battery compartment crack was found at the case seal below the grip pad. A battery compartment leak was demonstrated in a leak test. The threads on the battery compartment were stripped. No damages were found with the returned battery cap. The retuned battery cap and a test cap were unable to tighten properly onto the pump but were able to maintain electrical contacts to allow the pump to power on with auditory and vibratory features. No tactile issues were found with the buttons. A rewind/load/prime sequence and a 24-hour basal exercise were executed without any power interruption or any call service alarms. Pump casing was opened and evidence of moisture intrusion was found on the main printed circuit board and the support bracket.
 
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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 Key5497508
MDR Text Key40419008
Report Number2531779-2016-05783
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 02/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2016
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 Manufacturer03/16/2016
Was the Report Sent to FDA? Yes
Device Age22 MO
Event Location No Information
Date Manufacturer Received02/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2014
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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