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

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump has been returned to animas.Evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (battery life w/ moisture) issue.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 1/05/2017 with the following findings: a review of the pump¿s black box data showed evidence of a short battery life illustrated with a 19 count voltage drop on (b)(6) 2016.During visual inspection of the pump, it was observed that the battery compartment was cracked and there was moisture corrosion observed in the battery canister.It was also observed that the bolus button cover was damaged but the bolus button was still operable.A leak test was performed and failed due a battery compartment leak and a bolus button leak.The ¿ez-prime¿ steps were performed correctly and all electrical current draws were within specification.The initial ¿short battery life¿ complaint was not duplicated during the investigation.The pump¿s cover was removed and there was no further moisture ingress or any intermittent condition found to the printed circuit board (pcb) or to the cgm module.

• 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: 6108341
• MDR Text Key: 60362717
• Report Number: 2531779-2016-31512
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100044
• UDI-Public: 0110840406100044
• 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: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• 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: 11/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/24/2016
• 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: 23 YR
• Patient Weight: 125