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

Device Problem Device Issue (2379)

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 an other (unusual) issue.The reporter stated that they need a replacement pump but did not say reason.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the device caused or contributed to an adverse event.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 24-apr-2018 with the following findings: during the investigation, a review of the black box history showed data from the date of the complaint was overwritten.No abnormal activity was observed in the current black box history.A test cap was used to perform further testing.The pump¿s ¿ez-prime¿ steps were performed correctly with no errors occurring during the investigation.Investigators were unable to duplicate the ¿cs alarm¿ complaint.The pump¿s cover was removed, and no intermittent condition was found to the printed circuit board.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: 6220688
• MDR Text Key: 64024376
• Report Number: 2531779-2017-00101
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10840406100242
• UDI-Public: 0110840406100242
• Combination Product (y/n): N
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: 12/06/2016
• Supplement Dates FDA Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 65 YR