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

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Nausea (1970)

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

The reporter contacted animas on (b)(6) 2016 alleging the patient experienced hyperglycemia while on insulin pump therapy with blood glucose measuring 486 mg/dl with the symptom of nausea.This reported information does not meet animas' criteria for a reportable adverse event.Therefore, no patient harm is being reported in association with the alleged product malfunction.The reported alleged the pump experienced a call service alarm issue; the pump reportedly emitted a call service alarm 087-4a32001 and 087-000f during a basal delivery of insulin by the pump.This complaint is being reported because the occurrence of the alleged call service alarm during basal delivery remained unresolved after troubleshooting by animas customer technical support.

Manufacturer Narrative

Follow-up #1: date of submission (b)(6) 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 (b)(6) 2016 with the following findings: the pump alarmed with a call service alarm 069 during start up.A language corruption occurred at a component on the printed circuit board resulting in a call service alarm.

Manufacturer Narrative

Follow-up #1: date of submission: 04/08/2016.Device evaluation: unrelated to the original complaint the battery compartment was noted to be cracked on the side of the battery compartment from the threads traveling down along the side of the bumper to the case seal.

• 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: 5440143
• MDR Text Key: 38824050
• Report Number: 2531779-2016-03988
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2016
• 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: 03/28/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2015
• 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: 39 YR