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

Device Problems Electrical /Electronic Property Problem (1198); Structural Problem (2506)

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) 2017, the reporter contacted animas, alleging a power (damage) issue. It was alleged that the battery compartment was cracked with intermittent power. There was no indication that the product caused or contributed to an adverse event. This issue is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Device evaluation: the device has been returned and evaluated by product analysis on 03/08/2017 with the following findings: a review of the black box showed a power on reset event. A crack was found in the battery compartment at the threads to the left side of the grip pad down to the seal. The threads on the battery cap were stripped and were unable to fit. A test cap was able to fit for testing. The intermittent power issues was duplicated during the investigation. The rewind, load, and prime steps were performed successfully. The pump was run for 24 hours and no further loss of power issues occurred. Unrelated to the original complaint, moisture was found in the battery compartment. A leak test was performed and failed due to a crack in the battery compartment. The pump was opened to find no moisture.

• 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: 6278253
• MDR Text Key: 65973352
• Report Number: 2531779-2017-02118
• Device Sequence Number: 1
• Product Code: MDS
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 01/06/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 01/06/2017
• 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: Unkown