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

Device Problem Insufficient Information (3190)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 08/31/2016

Event Type  Injury  

Manufacturer Narrative

The pump has not been returned to animas.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 patient was hospitalized with diabetic ketoacidosis.No additional information was provided.Customer technical support made attempts to contact the reporter for additional information and troubleshooting, without success.This complaint is being reported based on the allegation that the patient was reportedly hospitalized for unspecified blood glucose excursion(s) and the pump could not be ruled out as a contributing factor.

Manufacturer Narrative

Follow-up #1 date of submission 01/20/2017-correction based on follow-up information: on 01/16/2017 the reporter contacted animas with additional information.Reportedly, the alleged hospitalization was due to the patient not changing the infusion set(s) appropriately per instructions for use.There was no indication or allegation that the alleged blood glucose excursion was associated with the pump, and there was no indication or allegation of a pump malfunction.Animas does not manufacture the infusion set therefore no regulatory report is required for that product.Animas will forward the complaint to the relevant manufacturer.

• 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: 5972959
• MDR Text Key: 55454975
• Report Number: 2531779-2016-26632
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100242
• UDI-Public: 0110840406100242
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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 Age: 64 YR
• Patient Weight: 217