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

Medical Device Problem Code	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 pump was returned and investigation at animas on 28-jun-2018 with the following findings: the battery compartment was found to be cracked on the side from the threads to the cover.
Event or Problem Description
On (b)(6) 2018, the reporter contacted animas, alleging a casing/condition (cracked/damaged casing) issue.It was reported that the battery compartment was cracked/damaged.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit.

• 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: 7651887
• Report Number: 2531779-2018-12051
• Device Sequence Number: 184331
• Product Code: OYC
• UDI-Device Identifier: 10840406100358
• UDI-Public: 10840406100358
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: 06/28/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 22 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 73