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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 Use of Incorrect Control Settings (1126)
Patient Problems Abdominal Pain (1685); Fatigue (1849); Hyperglycemia (1905); Nausea (1970); Blurred Vision (2137); Vomiting (2144); Diabetic Ketoacidosis (2364); Confusion/ Disorientation (2553); Polydipsia (2604)
Event Date 04/29/2016
Event Type  Injury  
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 and alleged that on (b)(6) 2016, the patient experienced a blood glucose (bg) value of 850 mg/dl with a large level of ketones, nausea, blurred vision, confusion, abdominal pain, extreme drowsiness, extreme thirst, and vomiting associated with an issue related to the suspend feature of the pump. Reportedly, the patient was hospitalized and received treatment from the health care provider, including intravenous fluids and insulin via injection, which was above and beyond the routine treatment of diabetes. The patient allegedly remained on insulin pump therapy. This complaint is being reported based on the allegation that the patient experienced hyperglycemia associated with the suspend setting issue.
 
Manufacturer Narrative
Follow-up #1: date of submission 06/23/2016. Device evaluation: the device has been returned and evaluated by product analysis on 06/07/2016 with the following findings: the pump's black box from the date of the event had been overwritten due to continued use of the pump. The available pump history showed that the pump was manually suspended on (b)(6) 2016 at 22:37. The pump was powered off for an unknown reason while suspended; the next recorded prime was on (b)(6) 2016 at 12:48. A rewind, load and prime sequence were successfully completed with no issues. The pump was exercised for a 24 hour duration period; no self-suspending occurred during this time period. No hypersensitive keys were observed on the keypad. The pump was able to be manually suspended and manually resumed with no issues. The daily insulin delivery totals correctly reflected the user's programmed basal rates. The pump passed a delivery accuracy test and was found to be delivering within the required range. The alleged issue could not be duplicated during the investigation. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
 
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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 Key5689013
MDR Text Key46217588
Report Number2531779-2016-10744
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 05/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Other Device ID Number011084040610002021949004116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age8 MO
Event Location No Information
Date Manufacturer Received05/10/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2015
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: 05/31/2016 Patient Sequence Number: 1
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