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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 Failure to Prime (1492)
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 an inability to prime the pump. It was reported that the patient experienced blood glucose over 250 mg/dl but less than 500 mg/dl without symptoms. The patient¿s blood glucose readings do not meet animas¿ criteria of a serious injury. However, this complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm. The device was replaced per reporter insistence and lost confidence.
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 01/03/2017 with the following findings: a review of the pump black box data revealed multiple loss of prime warnings associated with low and zero force readings. During testing, the pump was exercised for 24 hours and the rewind, load, and prime steps were completed successfully with no duplicated loss of prime warnings. The force sensor calibration measured within specifications. The pump case was removed, and no evidence of damage to the force sensor was found. Evidence of the complaint was found in the black box data; however, the complaint was not duplicated. Unrelated to the complaint, the top of the battery cap was worn, making the cap difficult to attach and remove.
 
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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 Key6123527
MDR Text Key60877978
Report Number2531779-2016-32071
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
Type of Report Initial,Followup
Report Date 10/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2016
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 Manufacturer11/23/2016
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received10/28/2016
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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