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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Dehydration (1807); Dyspnea (1816); Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553)
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
The reporter contacted animas on (b)(6) 2016 alleging the patient experienced a hyperglycemic event while on insulin pump therapy with blood glucose measuring >600 mg/dl accompanied by a dehydration, large urinary ketones, nausea, confusion and extreme lethargy and rapid, deep breathing. The patient did not receive any treatment above or beyond the usual routine of diabetes care and management. The patient self-administered insulin via injection to lower blood glucose. Troubleshooting by animas customer technical support revealed the patient was not priming the tubing fully during the load step. This complaint is being reported because the patient experienced a serious injury while on insulin pump therapy due to user error priming the pump.
 
Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 02/02/2017 with the following findings: unable to confirm or duplicate the complaint, the black box data and prime history for the complaint date (b)(6) 2016 has been overwritten. The black box shows dates from (b)(6) 2017 to (b)(6) 2017. Unable to verify if user was ¿priming the tubing fully during the load step¿ on event date due to overwritten data. A rewind, load, fill cartridge and fill cannula step were successfully completed. A 24hr duration test was successfully completed with no eaw¿s duplicated. The pump is detecting the correct force. #4. 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. Unable to confirm or duplicate the complaint, the pump information for the complaint date has been overwritten.
 
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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 Key5824749
MDR Text Key50511066
Report Number2531779-2016-17502
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 07/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Other Device ID Number011084040610005121978007416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/25/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age10 MO
Event Location No Information
Date Manufacturer Received07/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2015
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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