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

Medical Device Problem Code	Failure to Read Input Signal (1581)
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 13-aug-2018 with the following findings: during investigation, the keypad was intact with all the keys unresponsive to user presses.There was moisture observed behind the display lens.A leak test failed due to a base crack.The keypad cover was removed and there was no contamination found under the key contacts.The pump cover was removed and there was internal moisture found on the keypad flex connector.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a button/keypad (tactile changes/unresponsive) issue.It was reported that the ok and up button were under responsive to user presses.There is no indication that the product issue caused or contributed to an adverse event.The complaint is being reported because the issue has the ability to result in inadvertent or incorrect insulin delivery or the inability to use the pump.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7804370
• Report Number: 2531779-2018-15218
• Device Sequence Number: 1290634
• Product Code: OYC
• UDI-Device Identifier: 10840406100297
• UDI-Public: 10840406100297
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 08/05/2018

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: 08/10/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 15 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 47