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

Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Structural Problem (2506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 27-aug-2019 the following findings: during investigation, the pump was returned with a cracked battery compartment.The battery cap was also stripped and unable to secure to the pump in order to power on the pump.A test battery cap was used and was able to secure enough and power on the pump.A 12-duration test was completed with test cap with no power loss or rebooting duplicated.Unrelated to the original complaint, the pump powered on to a dim and discolored display.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.
Event or Problem Description
On 08-aug-2019, the reporter contacted animas, alleging a power (damage) issue.It was alleged that the battery compartment was cracked and the patient was unable to tighten the battery cap to the pump.There was no allegation of an adverse event associated with this complaint.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8939201
• Report Number: 2531779-2019-04488
• Device Sequence Number: 2458700
• Product Code: OYC
• UDI-Device Identifier: 10840406103137
• UDI-Public: 10840406103137
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR