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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 Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The pump has been returned to animas. Evaluation has not yet been completed. When evaluation is complete a supplemental report will be filed. No conclusion can be made at this time.
 
Event Description
On (b)(6) 2016, the reporter contacted animas, alleging a history/settings (inaccurate delivery) issue. No details were provided. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported as there is an allegation against the delivery function of the pump.
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 12/19/2016 with the following findings: a review of the pump histories indicated that the last bolus and last basal deliveries occurred on (b)(6) 2016. A review of the black box indicated the following: an ¿exceeded max 2 hour limit¿ warning occurred on (b)(6) 2016 at 19:24 and deliveries resumed at 20:03; an unexplained loss of prime warning occurred on (b)(6) 2016 at 09:04, the pump was powered off, and deliveries resumed on (b)(6) 2016 at 15:57. A review of the total daily dose history indicated that insulin delivery totals correctly reflected programmed values. The pump successfully completed a rewind, load, and prime sequence. 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. No delivery interruptions and no errors, alarms, or warnings occurred during investigation. (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 Key6081914
MDR Text Key59575813
Report Number2531779-2016-30694
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
PMA/PMN Number
P130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 10/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number1-MCBC-3762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2016
Was the Report Sent to FDA? Yes
Device Age10 MO
Event Location No Information
Date Manufacturer Received10/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2015
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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