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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); Diabetic Ketoacidosis (2364)
Event Date 06/08/2016
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 that on (b)(6) 2016. The patient experienced hyperglycemia while on insulin pump therapy with blood glucose measuring >500 mg/dl and positive urinary ketones. The reporter stated that patient was hospitalized with the diagnosis of diabetic ketoacidosis and was treated for the same with an undisclosed treatment plan. The reporter alleged an inaccurate delivery issue with the insulin pump; the basal history did not match the active basal program. Animas customer support attempted to contact the health care provider (hcp) for clarification of the event; however, was unable to reach the hcp. This complaint is being reported because the patient reportedly experienced a serious injury requiring hospitalization while on insulin pump therapy alleging the pump failed to deliver accurately.
 
Manufacturer Narrative
Follow-up #1: date of submission 07/25/2016. 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. Device evaluation: the device has been returned and evaluated by product analysis on 07/18/2016 with the following findings: review of the black box data revealed an unexplained loss of prime event on (b)(6) 2016 at 16:58 followed by ¿power on reset. ¿ power to pump was restored (b)(6) 2016 at 16:51. The pump was then manually suspended on (b)(6) 2016 at 16:52 and delivery by the pump was never resumed. On investigation, the pump was powered on and exercised for 24 hours on a 2. 0 unit/hour basal rate program. At the conclusion of the exercise, the basal history correctly reflected 2. 0 units and the total daily dose showed 48. 0 units delivered. The total daily doses added up correctly to reflect the user¿s programmed basal rates. The pump passed delivery accuracy testing without delivery defects. The pump was found to be delivering accurately and within the required range. No delivery interruptions, errors, alarms or warnings occurred during the investigation. Investigation did not duplicate the complaint. (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 Key5732063
MDR Text Key47598003
Report Number2531779-2016-12247
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 consumer,foreign
Type of Report Initial,Followup
Report Date 06/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Was the Report Sent to FDA? Yes
Device Age11 MO
Event Location No Information
Date Manufacturer Received06/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2015
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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