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

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device 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 and alleged that the pump had temperature issues.There was no damage to the pump.There was no allegation of an adverse event.This complaint is reported because of the potential for the user to experience an injury to the skin due to increased pump temperature.

Manufacturer Narrative

Follow-up #1 date of submission 01/06/2017-correction to initial reporter name: (b)(6).

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 2/13/2017 with the following findings: a review of the pump¿s black box and download history did not find any unusual voltage fluctuations.The battery compartment and battery cap were intact and the battery cap could be fully tightened onto the pump.The pump powered on normally with no overheating or alarms duplicated during the investigation.The pump¿s ¿ez-prime¿ steps were performed correctly and all of the pump's electrical current draws were found to be within specification.The pump cover was removed and there were no intermittent condition found to the printed circuit board (pcb) or to the continuous glucose monitoring (cgm).The investigation was unable to duplicate the initial ¿temperature¿ complaint.Unrelated to the initial complaint, it was observed that the cartridge compartment was missing a fragment around the threads contour but the returned cartridge cap was still able to fit onto the cartridge compartment.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: 6220117
• MDR Text Key: 63951543
• Report Number: 2531779-2017-00098
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100082
• UDI-Public: 0110840406100082
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 11 MO
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2015
• 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: 12 YR