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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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The pump has not been returned to animas for evaluation. 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 history/settings (inaccurate delivery) issue. There was no additional information available for this complaint. There was no indication that the product caused or contributed to an adverse event. This complaint is reportable as there is an allegation against the delivery function of the pump.
 
Manufacturer Narrative
Follow-up #1: date of submission 05/25/2016. Device evaluation: the device has been returned and evaluated by product analysis on 05/06/2016 with the following findings: the last basal delivery was on (b)(6) 2016. The pump history revealed that the pump was manually suspended on (b)(6) 2016 at 10:37 and manually resumed at 10:46. The last bolus delivery was a 0. 65 unit bolus on (b)(6) 2016 at 10:49. The total daily insulin delivery correctly reflected the user's programmed basal rates. The pump passed the delivery accuracy test and was found to be delivering within required range and delivering accurately. There were no delivery interruptions or any errors, alarms or warnings that occurred during the investigation. The reported inaccurate delivery complaint was unable to be duplicated during testing. Unrelated to the complaint, the battery compartment was found to be cracked on the side from the threads to cover.
 
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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 Key5605789
MDR Text Key44177220
Report Number2531779-2016-08456
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 04/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2016
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 Manufacturer04/28/2016
Was the Report Sent to FDA? Yes
Device Age13 MO
Event Location No Information
Date Manufacturer Received04/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2015
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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