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

Device Problem Retraction Problem (1536)

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 (b)(6) 2019, the reporter contacted animas, alleging a motor (rewind issue) issue.It was reported that the rewind stops prior to completion.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the issue may result in an inability to use the product which may lead to long term cessation of delivery.

Manufacturer Narrative

Device evaluation: the pump has been returned and evaluated by product analysis on 30-oct-2019 with the following findings: a review of the pump¿s black box showed cs 078 motor rewind alarm.During testing, a cs 078 alarm occurred during the rewind step.The pump was opened and an internal moisture found on the motor flex connector and surrounding components.A crack in the battery compartment was observed.Leak testing revealed a leak at the battery compartment.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 LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer (Section G): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• Manufacturer Contact: kristen lopolito ; 965 chesterbrook blvd; wayne, PA 19087
• MDR Report Key: 8886236
• MDR Text Key: 154099180
• Report Number: 2531779-2019-04351
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• 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: 10/29/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR