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 an inaccurate delivery issue.There was no indication that the product caused or contributed to an adverse event.Customer support has made several attempts to contact the reporter in follow up, however, the reporter did not respond.No further information was available; if further information is provided a follow up report shall be made.This complaint is being reported because of the allegation of an unspecified pump malfunction.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

The device was returned to animas and investigated by product analysis on 12/2/2016 with the following findings: review of the black box data revealed records beginning 05 oct 2016; the data records from the date of the complaint had been overwritten due to continued patient use.The available total daily doses added up correctly and reflected the user¿s programmed basal rates.On investigation, the pump powered on and emitted a call service alarm 069.The pump was unable to be cleared of the 069 call service alarm; a language corruption occurred at a component on the printed circuit board resulting in the call service alarm.Due to this issue, the pump was not able to be further investigated for the alleged inaccurate delivery issue.

• 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: 5503841
• MDR Text Key: 40667192
• Report Number: 2531779-2016-05968
• 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,Followup
• Report Date: 03/08/2016

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Initial Date Manufacturer Received: 03/08/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/22/2016; 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• 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: 10 YR