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

Device Problem Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 (b)(6) 2016 the reporter contacted animas alleging that the pump was not delivering insulin accurately.This complaint is being reported based on the allegation against the delivery function of the pump.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 12-jul-2018 with the following findings: during investigation, the last basal delivery was on 2018 (b)(6).The last delivered bolus was a 2.85u normal bolus on (b)(6) 2018.The black box showed an unexplained pump reboot on (b)(4) 2018.The pump was powered back on and deliveries resumed.The total daily dose added up correctly and reflect the users programmed basal rates.The pump passed delivery accuracy testing and was found to be delivering accurately and within range.The pump was exercised for 24hrs with a 2.0u/hr basal rate; at end testing the basal history correctly showed 2.0u and the total daily dose showed 48.0u.There were no errors, alarms or warnings or delivery interruptions occurring during the testing.Unable to duplicate the complaint.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• 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: 5779740
• MDR Text Key: 49771785
• Report Number: 2531779-2016-15309
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): Y
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 011084040610008221049201616
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 9 MO
• Initial Date Manufacturer Received: 06/26/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: 06/26/2016
• Supplement Dates FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2015
• 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 Age: 23 YR