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

Model Number	11420400
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Fail-Safe Problem (2936)
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 03/15/2016 device evaluation: the device has been returned and evaluated by product analysis on (b)(6) 2016 with the following findings: during testing, the pump was powered on and emitted a cs 069 call service alarm immediately upon attempting a rewind step.The call service alarm was recorded in the black box data as a cs 087 failure, indicating a language file corruption due to a failed u39 component on the printed circuit board.
Event or Problem Description
On (b)(6) 2016, the reporter contacted animas, alleging a call service alarm (call service alarm issue) issue.It was noted that the pump emitted a cs 069 service alarm.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 10528171
• Report Number: 2531779-2020-00258
• Device Sequence Number: 3118355
• Product Code: OYC
• UDI-Device Identifier: 10840406100020
• UDI-Public: 10840406100020
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 03/09/2016

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
• Operator of Device: Lay User/Patient
• Device Model Number: 11420400
• Device Catalogue Number: 11420400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2016
• 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: 7 YR