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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 Inaccurate Delivery (2339)
Patient Problems Headache (1880); Hyperglycemia (1905); Dizziness (2194); Confusion/ Disorientation (2553)
Event Type  malfunction  
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 (b)(6) 2016, the reporter contacted animas alleging a blood glucose of 5. 8 mmol/l with dizziness, confusion, and a headache related to an inaccurate delivery issue. The patient reportedly self treated the blood glucose with oral carbohydrates. The reported blood glucose does not meet animas criteria for an adverse event. Troubleshooting of the event was unable to be completed at the time of contact. Animas attempted to follow up with the reporter but has been unsuccessful at this time. This complaint is being reported because the reported issue was not resolved with troubleshooting. There was no adverse event associated with this complaint.
 
Manufacturer Narrative
Follow up #1 09/22/2016. Device evaluation: the pump has been returned to animas and evaluated on 08/27/2016 with the following findings: the last recorded basal and bolus deliveries were on (b)(4) 2016. The recorded total daily doses of insulin correctly added up to the expected amount. The pump passed a delivery accuracy test and was found to be delivering within the required range. There were no delivery interruptions or alarms observed during the investigation. The alleged issue could not be duplicated.
 
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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 Key5577981
MDR Text Key43165469
Report Number2531779-2016-07852
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 04/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2016
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 Manufacturer08/09/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age17 MO
Event Location No Information
Date Manufacturer Received04/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/10/2014
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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