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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 Electromagnetic Interference (1194)
Patient Problems Fatigue (1849); Hyperglycemia (1905)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas for evaluation. An evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time. (b)(4).
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging that the patient experienced hyperglycemia while on insulin pump therapy with blood glucose measuring >250 mg/dl and extreme drowsiness. The reporter stated the adjustments had been made to the basal rate and the bolus settings of the pump. Additionally, the pump was exposed to extreme environmental conditions; the pump experienced x-ray exposure. The owner's booklet instructs the user to not expose the pump to very strong electromagnetic fields because those strong magnetic fields can re-magnetize the portion of the motor that regulates insulin delivery. The user is advised to remove the pump and keep it outside of the x-ray room unless a lead apron that completely covers the pump is worn during the procedure. This complaint is being reported because the patient reportedly experienced a serious injury while on insulin pump therapy related to an environmental exposure issue.
 
Manufacturer Narrative
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. Device evaluation: the device has been returned and evaluated by product analysis on 07/21/2016 with the following findings: review of the black box data revealed the last basal delivery and the last bolus delivery were on (b)(6) 2016. On investigation, the pump powers on to the verify screen with vibratory and audible features as per normal operation. An ez-prime sequence and 24 hour duration test were successfully completed. The daily insulin delivery totals correctly reflect user's programmed basal rates. The pump passed delivery accuracy test and was found to be delivering within required range and delivering accurately. Patient negligence issue - pump subjected to conditions outside specifications.
 
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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 Key5785490
MDR Text Key50009753
Report Number2531779-2016-15607
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 06/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610021121371122316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age2 MO
Event Location No Information
Date Manufacturer Received06/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2016
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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