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

Medical Device Problem Codes	Moisture Damage (1405); 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
Follow-up #1: date of submission 23-feb-2018 - device evaluation: the device has been returned and evaluated by product analysis on 23-feb-2018 with the following findings: during the investigation, the audio bolus button cover was found to be missing.Moisture was observed under the display lens.Unrelated to the original complaint, the battery compartment was found to be cracked from the threads to the left of the grip pad.A leak test failed due to the battery compartment leak.The cartridge compartment was also found to be cracked.The pump was opened, and moisture was observed on all the internal components.The pump powered on to a blank display.Multiple cs054/52's alarms were observed during a review of the black box.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 (b)(6) 2018, the reporter contacted animas, alleging the audio bolus button was missing with moisture present behind the display and near the audio bolus button.There was no indication that the product caused or contributed to an adverse event.The complaint is being reported because the issue has the ability to result in inadvertent or incorrect boluses which may result in over or under delivery.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• MDR Report Key: 7292555
• Report Number: 2531779-2018-04107
• Device Sequence Number: 13765507
• Product Code: OYC
• UDI-Device Identifier: 10840406100280
• UDI-Public: 10840406100280
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 20 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR