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

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

On (b)(6) 2016, the reporter contacted animas, alleging a temperature issue.No physical damage to the pump was reported.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.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 02-aug-2019 with the following findings: a review of the pump black box or download history showed any activity related to temperature issues.No sudden drop in voltage readings was observed.A visual inspection of the pump revealed no evidence of damage to the battery compartment or returned battery cap.There was no evidence of moisture contamination inside the battery compartment.The returned battery cap was able to fit securely to maintain an electrical connection.The pump powered on and was exercised for 12 hours with no warnings, overheating, or power loss duplicated.The pump electrical current draws were within specification.The pump¿s cover was removed and no evidence of moisture or defects were observed to the power components.The complaint of a temperature issue was not duplicated during investigation.There was no defect 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
• Type of Device: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer (Section G): ANIMAS CORPORATION; 200 lawrence dr; west chester PA 19380 3428
• Manufacturer Contact: karin sargrad ; 200 lawrence dr; west chester, PA 19380-3428 ; 4843561808
• MDR Report Key: 6129621
• MDR Text Key: 61233525
• Report Number: 2531779-2016-32275
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100068
• UDI-Public: 0110840406100068
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-MCBC-3762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 17 MO
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 155