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

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Event Description

On (b)(6) 2016, the reporter contacted animas, and alleged that that the cgm glucose above limit does not display on the pump screen.There was no indication that the device caused or contributed to an adverse event.This complaint is being reported because the issue may cause the user to miss an alarm or warning that may cause cessation of insulin delivery.

Manufacturer Narrative

Follow-up #1: date of submission 10/04/2016 - device evaluation: the pump has been returned and evaluated by product analysis on 09/08/2016 with the following findings: a review of the black box and cgm history showed cs213 bg above limit warnings.A review of user settings showed cgm high limit alert was enabled and set to 200mg/dl with 0 minute snooze time.During testing, a test transmitter paired successfully with a test pump.During testing, blood glucose (bg) value was set to 120 mg/dl twice within two hours.Both bg calibration requests entered successfully.The pump and transmitter were run over night with a steady reading of 115 mg/dl within +/- 20%.When a test cs213 warning was simulated with 120mg/dl as the threshold and 0 min as snooze time, the pump gave the appropriate cs213 warning as an audible and visible alert.The pump performed appropriately.The original complaint of a cgm warning not being displayed was not able to be duplicated during investigation.There was no defect found.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.

• 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: 5848973
• MDR Text Key: 52551473
• Report Number: 2531779-2016-19000
• 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: 07/07/2016

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: 011084040610023521761543116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 2 MO
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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: 18 YR