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

Model Number	11451100
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up #1: date of submission 03/17/2017 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.Device evaluation: the device has been returned and evaluated by product analysis on 02/27/2017 with the following findings: on examination, the battery compartment and battery cap were intact and without damage; the cap was able to secure to the pump properly.There was no evidence of moisture inside the battery compartment.On investigation, the pump powered on with functioning auditory tone and vibration; however, the display screen remained blank.Investigation did not duplicate the alleged ¿no power¿; the pump had power as evidenced by the functioning audio tone and vibration features.The pump was opened for further investigation and revealed moisture damage inside the pump affecting the printed circuit board.A blank display screen can give the appearance of no power to the pump; however, in the instance of functioning audio tone and vibration, power to the pump is confirmed.
Event or Problem Description
On (b)(6) 2016, the reporter contacted animas, alleging a no power issue.There was no allegation of an adverse event with this complaint.Customer support has made several attempts to contact the reporter in follow up, however, the reporter did not respond.No further information was available; if further information is provided a follow up report shall be made.This complaint is being reported because of the allegation of a power issue.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 10527928
• Report Number: 2531779-2020-00249
• Device Sequence Number: 3056070
• Product Code: OYC
• UDI-Device Identifier: 10840406100051
• UDI-Public: 10840406100051
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: 11451100
• Device Catalogue Number: 11451100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR