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

Device Problems Premature Discharge of Battery (1057); Moisture Damage (1405); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

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

On 10/23/2016, the reporter contacted animas, alleging that the pump had shorter than expected battery life.The reporter stated that the battery compartment was cracked and moisture was present.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

Manufacturer Narrative

The device has been returned and evaluated by product analysis on 01/10/2017 with the following findings: a review of the black box showed evidence of a short battery life, unexplained power on reset events, and battery alarms following power on reset events.The battery compartment was cracked the thread area, and below the grip pad.The battery compartment threads were damaged.The battery cap threads were damaged.The battery cap was unable to be fully tightened.Evidence of moisture contamination was found inside the battery compartment, and in the underside of the battery cap contact hub.A leak test was performed and failed due to a leak at the battery compartment crack.Rewind, load, and prime steps were performed successfully without any power interruptions.The pump intermittently powered on with the returned battery cap and the test battery cap.The current draws were within specifications.The pump case was removed to find no evidence of additional moisture inside the pump.A battery life issue was not duplicated during investigation.

• 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: 6101278
• MDR Text Key: 60093967
• Report Number: 2531779-2016-31337
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100020
• UDI-Public: 0110840406100020
• 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: 10/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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: 11/16/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/23/2016
• 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: 9 YR