MAUDE Adverse Event Report: ANIMAS CORPORATION ANIMAS VIBE; OYC

Device Problem Break (1069)

Patient Problems Swelling (2091); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The device 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.

Event Description

On (b)(6) 2016, the reporter contacted animas and alleged that the patient had required surgery to remove broken sensor wires.The patient had started a new cgm session 1 month ago and used the sensor for 7 days before removing it from the skin.Approximately 3 weeks after the end of the session, patient's arm was swollen and had red marks.After examination, it was discovered that the little wires had broken off the sensor and the patient needed surgery to retrieve them.This complaint is being reported as the patient required surgical intervention to remove the sensor wires.

• Brand Name: ANIMAS VIBE
• Type of Device: OYC
• 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: 5754913
• MDR Text Key: 48318553
• Report Number: 2531779-2016-13673
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention