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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 Hyperglycemia (1905); Vomiting (2144)
Event Type  Injury  
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 06/07/2016, the reporter contacted animas, alleging a history settings (inaccurate delivery) issue. The reporter stated that the patient had a blood glucose (bg) of 600mg/dl with vomiting. The patient did not receive any treatment above and beyond the usual routine care of diabetes management. Customer support (cs) was unable to reach the patient for additional information. This report is being made due to the bg excursion the patient experienced due to an alleged history settings issue.
 
Manufacturer Narrative
The device has been returned and evaluated by product analysis on 03/24/2017 with the following findings: unable to duplicate the complaint, the pump information for the complaint date has been overwritten. The black box begins on (b)(6) 2017. Due to continuous use of the pump the black box data/histories for the event have been overwritten. Available daily insulin delivery totals correctly reflect the users programmed basal rates. Pump passed delivery accuracy test and was found to be delivering within required range and delivering accurately.
 
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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 Key5748946
MDR Text Key48151312
Report Number2531779-2016-13270
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 06/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610019821341015316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age3 MO
Event Location No Information
Date Manufacturer Received06/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2016
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: 06/24/2016 Patient Sequence Number: 1
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