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

Device Problems Crack (1135); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 (b)(6) 2016, the reporter contacted animas, alleging a casing/condition (cracked/damaged casing) issue.The reporter alleged damage to the battery compartment.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.

Manufacturer Narrative

Follow-up #1: date of submission 08/30/2016.Device evaluation: the device has been returned and evaluated by product analysis on 08/27/2016 with the following findings: investigation revealed cracks in the battery compartment.Unrelated to the original complaint, the audio bolus button cover was damaged; however, the bolus button was responsive during the investigation.Evidence of moisture was observed in the battery compartment; a leak test failed due to a battery compartment leak.The pump was opened and no further evidence of moisture was found internally.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: 5847824
• MDR Text Key: 52566566
• Report Number: 2531779-2016-18948
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/26/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 10 MO
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2015
• 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: 15 YR