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

Device Problems Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)

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 call service alarm (call service alarm issue) issue.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 a long term cessation of insulin delivery if the user is unable to resolve the alarm.

Manufacturer Narrative

Follow-up #1: date of submission 22-jan-2020 - device evaluation: the pump has been returned and evaluated by product analysis on 16-jan-2020 with the following findings: a review of the pump¿s black box history showed cs 012 call service alarm 15-dec-2019.During investigation the 12 hour basal duration test could not reproduce cs 012 alarm.The pump was opened and internal moisture corrosion was found on internal components.The complaint of a call service alarm issue was shown in the pump history but was not duplicated during testing.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.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.

• Brand Name: ANIMAS VIBE
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 9488325
• MDR Text Key: 171826006
• Report Number: 2531779-2019-06165
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• 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: 01/14/2020
• Was the Report Sent to FDA?: Yes
• Device Age: 29 MO
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR