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
The pump was returned to animas for evaluation.When evaluation is completed, a supplemental report will be filed.No conclusions can be made at this time.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (damage) issue.It was reported that the battery compartment was cracked and that the cap would not remain tightened to the pump.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.
Additional Manufacturer Narrative
Date of submission (b)(6)2018 device evaluation: the device has been returned and evaluated by product analysis on (b)(6)2018 with the following findings: a review of the black box showed no evidence of a "no power" event.No battery cap or cartridge cap were returned.All testing was performed with test caps.The pump powered up with a test battery cap.The test battery cap was unable to fully tighten.The battery compartment cracks were observed from the thread area to the case seal and below the grip pad.No evidence of moisture was found inside the battery compartment.A 24 hour basal program was run with a test battery cap and no reboots, power losses, or call service alarms were duplicated.The pump case was removed to find no evidence of moisture or loose components inside the pump.A "no power" event was not duplicated during investigation.

• 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: 7746228
• Report Number: 2531779-2018-14111
• Device Sequence Number: 1860976
• Product Code: OYC
• UDI-Device Identifier: 10840406100259
• UDI-Public: 10840406100259
• 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
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2018

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: 08/01/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR