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

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 power (intermittent power) issue. There was no indication that the product caused or contributed to an adverse event. This complaint is being reported because the user may be unaware that the pump has lost power, leading to under delivery.

Manufacturer Narrative

Follow-up #1: date of submission 06/27/2016 - device evaluation: the pump has been returned and evaluated by product analysis on 06/13/2016 with the following findings: a review of the pump black box data revealed multiple pump reboots. During a visual inspection of the pump, the battery compartment was found to be cracked. The returned battery cap secured properly to the pump, and a power loss was not observed. Battery cap contacts height and width measurements were within required specifications. The pump was exercised for 24 hours with no power interruptions. The pump case was removed, and no evidence of damage to the power circuit was found. The complaint of a power issue was shown in the pump history but was not duplicated during investigation.

• 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: 5674933
• MDR Text Key: 45806793
• Report Number: 2531779-2016-10368
• 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: 05/10/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Other Device ID Number: 011084040610005121366483516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 14 MO
• Event Location: No Information
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown