MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; INSULIN INFUSION PUMP

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.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN 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 Key: 5748946
• MDR Text Key: 48151312
• Report Number: 2531779-2016-13270
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• 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 Received: 06/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610019821341015316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 8 YR
• Patient Weight: 40