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

Device Problem Failure to Prime (1492)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 an inability to prime the pump.It was reported that the patient experienced blood glucose over 250 mg/dl but less than 500 mg/dl without symptoms.The patient¿s blood glucose readings do not meet animas¿ criteria of a serious injury.However, this complaint is being reported because the issue may result in a long term cessation of insulin delivery if the user is unable to resolve the alarm.The device was replaced per reporter insistence and lost confidence.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 01/03/2017 with the following findings: a review of the pump black box data revealed multiple loss of prime warnings associated with low and zero force readings.During testing, the pump was exercised for 24 hours and the rewind, load, and prime steps were completed successfully with no duplicated loss of prime warnings.The force sensor calibration measured within specifications.The pump case was removed, and no evidence of damage to the force sensor was found.Evidence of the complaint was found in the black box data; however, the complaint was not duplicated.Unrelated to the complaint, the top of the battery cap was worn, making the cap difficult to attach and remove.

• 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: 6123527
• MDR Text Key: 60877978
• Report Number: 2531779-2016-32071
• 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
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• 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: 11/23/2016
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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