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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 Noise, Audible (3273)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
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 that on an unspecified date, the patient experienced elevated blood glucose (bg) of "high" (>600mg/dl) with no reported signs or symptoms of hyperglycemia. Reportedly, the patient did not receive any treatment above and beyond the usual routine of diabetes care and management and discontinued insulin pump therapy. The reporter noted that the pump's motor was making a grinding noise and was loud during the rewind and prime steps. The reporter stated that they felt the issue was impacting insulin delivery. This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with a motor issue.
 
Manufacturer Narrative
Follow-up #1: date of submission 07/28/2016. Device evaluation: the device has been returned and evaluated by product analysis on 07/07/2016 with the following findings: a review of the pump histories did not find any errors, alarms, or warnings associated with the complaint. A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values. Multiple rewind, load, and prime steps were performed successfully with no motor noises occurring. The pump was exercised for 24 hours with no issues occurring. The pump passed delivery accuracy testing and was found to be delivering within required specifications. The pump cover was removed and no internal defects were found. The complaint could not be confirmed or duplicated on investigation.
 
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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 Key5768927
MDR Text Key48743549
Report Number2531779-2016-14555
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 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610035821590370116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age1 MO
Event Location No Information
Date Manufacturer Received06/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/05/2016 Patient Sequence Number: 1
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