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

Device Problems Electrical /Electronic Property Problem (1198); Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The pump has been returned to animas but evaluation has not yet been completed.When evaluation is complete a supplemental report will be filed.No conclusion can be made at this time.(b)(6).

Event Description

On (b)(6) 2016, the reporter contacted animas, alleging a power (moisture ingress) issue.There was reportedly moisture and corrosion in the battery compartment.There was no indication of damage to the pump.There was no indication that the product caused or contributed to an adverse event.This is reportable because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Follow-up #1: date of submission 01/05/2017.Device evaluation: the device has been returned and evaluated by product analysis on 12/20/2016 with the following findings: during testing, the pump did not power on due to moisture damage in the form of rust and corrosion in the battery compartment; the complaint was duplicated.A visual inspection of the pump revealed a cracked battery compartment.A leak test was performed and failed due to a battery compartment leak.The pump case was removed, and no further moisture damage or other damage was observed to the pump interior or power circuit.Unrelated to the complaint, the bolus button cover was punctured.

• 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: 6079296
• MDR Text Key: 59461911
• Report Number: 2531779-2016-30615
• 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: distributor,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• 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: 11/04/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Date Manufacturer Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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