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 26-jul-2018 with the following findings: during the investigation, a review of the black box showed several unexplained power reset events.The battery compartment was found to be cracked at the threads on the side.The returned battery cap was undamaged and able to fit.The battery cap was fastened and then unscrewed a half a turn with no power reboots occurring.The pump¿s ¿ez-prime¿ steps were performed correctly, and no power interruptions occurred during the investigation.Investigators were unable to duplicate the ¿power¿ complaint.The pump¿s cover was removed, and no intermittent condition was found to the power printed circuit board.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a power (damage) issue.The reporter alleged the battery compartment was cracked.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.

• 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: 7730416
• Report Number: 2531779-2018-13698
• Device Sequence Number: 13804103
• Product Code: OYC
• UDI-Device Identifier: 10840406100259
• UDI-Public: 10840406100259
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 07/07/2018

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: 07/19/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 160