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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 No Audible Alarm (1019)
Patient Problems Hyperglycemia (1905); Nausea (1970); Confusion/ Disorientation (2553); Lethargy (2560)
Event Type  Injury  
Manufacturer Narrative
The pump has been returned to animas. 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 and alleged the following: patient states the pump did not alert for a blood glucose was above the limit from 9:26pm until 5:56am, when a glucose rise rate warning was received. Her snooze time is set for 90 minutes, and she did not receive an alarm all night. Patient had a blood glucose of 367 mg/dl, with confusion, lethargy, and nausea, but received no unusual treatment. Patient's medical history includes high blood pressure, a sleep disorder, and fibromyalgia. This complaint is being reported as the patient experienced hyperglycemia when the alert was not emitted.
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 05/17/2017 with the following findings: during investigation the last basal delivery was on (b)(6) 2016. The total daily dose added up correctly and reflected the programmed basal rate target. The pump reflected the 24 unit after 24 hours on a 1 unit/ hr duration. The product delivered within specification. The complaint could not be confirmed during testing and the investigation concluded with no defects found to the pump. 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. (b)(4).
 
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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 Key5678526
MDR Text Key45883238
Report Number2531779-2016-10485
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 04/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610008221939874916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age5 MO
Event Location No Information
Date Manufacturer Received04/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2015
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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