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

Medical Device Problem Code	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 - no physical damage) issue.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 pump has been returned and evaluated by product analysis on 14-jul-2018 with the following findings: a review of the black box showed data from the dates from (b)(6) 2018 to end of pump use on (b)(6) 2018.The event was reported to have occurred on (b)(6) 2018.The black box verified a sudden voltage drop on (b)(6) 2018.During investigation, the pump electrical current draws were within specification.The pump was opened and no evidence of moisture was observed in the battery compartment or inside the pump.The power flex and components were inspected with no defects found.There was no damage observed to the power circuit.The complaint of temperature issue 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: 7605778
• Report Number: 2531779-2018-11045
• Device Sequence Number: 2018209
• Product Code: OYC
• UDI-Device Identifier: 10840406100358
• UDI-Public: 10840406100358
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 06/07/2018

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
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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