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

Medical Device Problem Codes	Structural Problem (2506); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and 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 temperature (temp - physical damage) issue.It was reported that the battery compartment was damaged.There was no indication that the product caused or contributed to an adverse event.This complaint is being reported because there is the potential for the user to experience an injury to the skin due to increased pump temperature.
Additional Manufacturer Narrative
Device evaluation: the device has been returned and evaluated by product analysis on 04-oct-2019 with the following findings: during investigation, there was no activity related to pi observed in black box or download history.There was no voltage drops in black box.No overheating duplicated during testing.Pump electrical current draws found within specification.The battery compartment is cracked.Corrosion in battery compartment.Pump leaks at battery compartment.Pump opened; no further evidence of moisture found.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.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8105794
• Report Number: 2531779-2018-20036
• Device Sequence Number: 16619416
• Product Code: OYC
• UDI-Device Identifier: 10840406100044
• UDI-Public: 10840406100044
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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): 11/21/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 35 MO
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 137