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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 Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Death (1802); Diabetic Ketoacidosis (2364)
Event Date 12/07/2015
Event Type  Death  
Manufacturer Narrative
Device evaluation: the pump has been returned and evaluated by product analysis on 22-jan-2018 with the following findings: a review of the black box showed an unexplained power on reset event, and the pump was powered on by the user but a prime was not performed to resume deliveries. The first basal program totaled 10. 2 units per day and the second basal program was programmed with a total of 0. 625 units per day. The black box showed multiple call service 163 and 165 max total daily dose limit warnings with deliveries resumed. The returned battery cap tightened securely to the pump with no power losses or reboots. The force sensor measured within specifications, and the auditory and vibratory alarms were functional. The pump passed delivery accuracy testing with no delivery defects. The pump was delivering accurately and within range. The pump cover was removed to find no internal moisture or force sensor defects. The history settings issue was unable to be duplicated during investigation.
 
Manufacturer Narrative
The product 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 01/25/2016, animas was notified that the patient was deceased. The reporter indicated that the patient was hospitalized for diabetic ketoacidosis with a blood glucose over 1000 mg/dl while wearing the pump. The reporter indicated that the patient was experiencing elevated blood glucose levels while wearing the vibe insulin pump however, the patient had not changed the site or treated with an insulin injection. The reporter indicated that the patient was treated for diabetic ketoacidosis and discharged from the hospital. Two days after the patient was discharged from the hospital, the patient suffered a cardiac event and passed away. It is unclear if the patient was using or attached to the pump at the time of the cardiac event. No additional information was available related to the event. This report is made based on the indication that the patient was hospitalized and subsequently passed away and the use of the insulin pump could not be ruled out as a contributor to the event.
 
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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 Key5442364
MDR Text Key101390268
Report Number2531779-2016-04063
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 company representative
Reporter Occupation Other Caregivers
Type of Report Initial,Followup
Report Date 01/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID Number011084040610007521558833316
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Device Age4 MO
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2015
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: 02/17/2016 Patient Sequence Number: 1
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